Role & responsibilities Implement EHS policies, procedures, and programs to ensure compliance with relevant EHS laws, regulations, and standards, including ISO 45001 and ISO 14001. Represent Company in external audits like Statutory & Notified body. Conduct regular inspections, audits, and risk assessments to identify potential hazards, evaluate existing controls, and recommend improvements. Implement, and establish safe work practices. Collaborate with cross-functional teams to ensure that all statutory compliance requirements related to environment, health, and safety are met. Design and deliver training programs on EHS topics to enhance employee awareness, knowledge, and compliance with safety protocols. Foster a strong safety culture throughout the organization by promoting best practices, providing guidance, and engaging employees in safety initiatives. Monitor waste management, emissions, and environmental impact. Ensure safe disposal of hazardous materials. Promote energy and resource conservation initiatives. Lead incident investigations, root cause analysis, and implement corrective actions to prevent recurrence. Monitor and track EHS performance metrics, prepare reports Stay up to date with emerging EHS regulations, industry trends, and best practices, and ensure timely implementation and compliance within the organization. Liaise with regulatory agencies, external auditors, and other stakeholders on EHS matters Ensuring compliance with all reporting and documentation requirements. Develop and maintain effective emergency response plans and procedures, conducting drills and exercises periodically. Collaborate with engineering and maintenance teams to ensure that equipment, machinery, and facilities meet EHS requirements. Monitor the compliance status of all corrective and preventive action and safety committee and audit points. Monitoring the effectiveness of the safety culture enhancement system. Assisting Manager HSE for all HSE related activities Preferred candidate profile In-depth knowledge of ISO 45001 and ISO 14001 standards and their implementation. Familiarity with Indian EHS laws, regulations, and statutory requirements. Strong understanding of safety management systems, risk assessment techniques, and accident investigation methodologies. Excellent communication and interpersonal skills to effectively engage and train employees at all levels of the organization. Well verse with local language (Malayalam) and English. Analytical mindset with the ability to collect, analyze, and interpret EHS data and metrics. Proactive approach to problem-solving, with a strong attention to detail and the ability to prioritize tasks effectively. Proficiency in computer applications, including MS Office and EHS management software

Requisition ID: 33764 At Terumo Blood and Cell Technologies, our 7,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. JOB TITLE: HSE Executive JOB SUMMARY: The role will be responsible for overseeing and implementing various environmental, health, and safety programs within the organization. The ideal candidate should have a strong background in EHS management, possess a thorough understanding of ISO 45001 and ISO 14001 standards, and have a track record of successfully improving safety culture and compliance. This role requires a strong understanding of EHS regulations in India, as well as the ability to effectively implement and maintain EHS programs ESSENTIAL DUTIES: Implement EHS policies, procedures, and programs to ensure compliance with relevant EHS laws, regulations, and standards, including ISO 45001 and ISO 14001. Represent Company in external audits like Statutory & Notified body. Conduct regular inspections, audits, and risk assessments to identify potential hazards, evaluate existing controls, and recommend improvements. Implement, and establish safe work practices. Collaborate with cross-functional teams to ensure that all statutory compliance requirements related to environment, health, and safety are met. Design and deliver training programs on EHS topics to enhance employee awareness, knowledge, and compliance with safety protocols. Foster a strong safety culture throughout the organization by promoting best practices, providing guidance, and engaging employees in safety initiatives. Monitor waste management, emissions, and environmental impact. Ensure safe disposal of hazardous materials. Promote energy and resource conservation initiatives. Lead incident investigations, root cause analysis, and implement corrective actions to prevent recurrence. Monitor and track EHS performance metrics, prepare reportsStay up to date with emerging EHS regulations, industry trends, and best practices, and ensure timely implementation and compliance within the organization. Liaise with regulatory agencies, external auditors, and other stakeholders on EHS mattersEnsuring compliance with all reporting and documentation requirements. Develop and maintain effective emergency response plans and procedures, conducting drills and exercises periodically. Collaborate with engineering and maintenance teams to ensure that equipment, machinery, and facilities meet EHS requirements. Monitor the compliance status of all corrective and preventive action and safety committee and audit points. Monitoring the effectiveness of the safety culture enhancement system. Assisting Manager HSE for all HSE related activities Minimum Qualification Requirements Education : A recognized degree in any branch of engineering or technology and possesses a degree or diploma in industrial safety recognized by the State Government in this behalf. Or An Engineering Degree in Fire & Safety / Industrial Safety from a recognised university Or A degree in any branch of engineering or technology from a recognized university and possess an M. Tech in Fire & Safety / Industrial Safety from a recognized university Experience : Minimum 3 Years in a similar role in Manufacturing Skills In-depth knowledge of ISO 45001 and ISO 14001 standards and their implementation. Familiarity with Indian EHS laws, regulations, and statutory requirements. Strong understanding of safety management systems, risk assessment techniques, and accident investigation methodologies. Excellent communication and interpersonal skills to effectively engage and train employees at all levels of the organization. Well verse with local language (Malayalam) and English. Analytical mindset with the ability to collect, analyze, and interpret EHS data and metrics. Proactive approach to problem-solving, with a strong attention to detail and the ability to prioritize tasks effectively. Proficiency in computer applications, including MS Office and EHS management software Physical Requirements Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 60 pounds. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue. We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare. Respect – Appreciative of othersIntegrity – Guided by our missionCare – Empathetic to patientsQuality – Committed to excellenceCreativity – Striving for innovation

Requisition ID: 33428 At Terumo Blood and Cell Technologies, our 7,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. We are seeking a skilled Maintenance Engineer with expertise in machine software, Electrical, Pneumatic and mechanical systems to oversee the maintenance, repair, and optimization of our equipment. The ideal candidate will have a strong background in software-controlled machinery and ensure maximum uptime and efficiency of production systems. Key Responsibilities: Maintenance Operations: Perform routine and preventive maintenance on machines and equipment to ensure optimal performance and reduce downtime. Troubleshooting: Diagnose and resolve mechanical, electrical, and software-related issues in production equipment. Software Management: Install, update, and configure machine control software, including PLCs, HMIs, VFDs and Servo drives. System Optimization: Analyze machine performance data to identify opportunities for efficiency improvements and implement changes. Documentation: Maintain accurate records of maintenance activities, including logs, reports, and software versioning. Compliance: Ensure all maintenance activities comply with safety, environmental, and quality standards. (GMP, ISO 9001, ISO13485, ISO14001, ISO45001) Collaboration: Work closely with production, quality, and engineering teams to address equipment issues and implement process improvements. Training: Provide technical support and training to operators and junior staff on equipment usage and software systems. Qualifications and Skills: Education: B tech in Electronics, Electrical, or Software Engineering, or a related field. Experience: 5+ years of experience as a Maintenance Engineer, preferably in a manufacturing or industrial setting. Technical Skills: Proficiency in PLC programming, CNC controls, and automation systems. Strong understanding of mechanical and electrical systems. Familiarity with software diagnostic tools and communication protocols (e.g., Modbus, Ethernet/IP). Ability to read and interpret technical drawings, schematics, and software logic diagrams. Soft Skills: Strong problem-solving and analytical skills. Excellent communication and teamwork abilities. Detail-oriented with a proactive approach to maintenance tasks. Certifications (Preferred): Electrical supervisory license. Work Environment: On-site in a manufacturing or industrial setting. May require occasional overtime or holiday shifts for urgent maintenance tasks. Exposure to machinery noise, moving equipment, and industrial environments. Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue. We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare. Respect – Appreciative of others Integrity – Guided by our mission Care – Empathetic to patients Quality – Committed to excellence Creativity – Striving for innovation Show more Show less

JOB SUMMARY We are looking for a highly skilled and experienced Senior Embedded Systems Engineer to join our dynamic team. In this role, he/ she will: Be responsible for Designing, developing, and maintaining embedded systems and software for medical devices. Work closely with cross-functional teams to ensure the successful integration of hardware and software components. Be responsible for optimizing system performance, ensuring reliability, and meeting project deadlines. Have a strong background in embedded systems, excellent problem-solving skills, and the ability to work independently as well as part of a team. Be expected to stay up to date with the latest industry trends and technologies and apply this knowledge to improve our products and processes. Independently conduct design change impact assessment, coordinate technical reviews of the changes, conduct failure analysis and potential risk impact assessment as part of a cross-functional Team. ESSENTIAL DUTIES Translate user and business requirements into detailed product requirement specifications and design specifications. Apply design controls with extensive knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 for medical device development. Design and develop embedded systems and software for medical devices. Collaborate with cross-functional teams to integrate hardware and software components. Optimize system performance and ensure reliability. Troubleshoot and resolve issues related to embedded systems. Document design specifications, test procedures, and results. Stay current with industry trends and technologies. Participate in code reviews and provide constructive feedback. Mentor junior engineers and provide technical guidance. Contribute to the continuous improvement of development processes. Ensure compliance with industry standards and regulations. Manage project timelines and deliverables. Apply Six Sigma and Lean principles to enhance efficiency and minimize waste. Define integration and verification plans with experience in budgeting adequate resources and time for execution of the plans Create, maintain and release Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) Conduct Technical reviews to root cause issues, perform tradeoff analysis, document key design considerations for future reference OTHER DUTIES AND RESPONSIBILITIES Work direction responsibility may include technicians and junior engineers. May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues. May contribute to the establishment of business objectives, goals, budgets, and costs. MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Bachelor of Science degree or Master of Science degree in Engineering preferred. Experience Minimum of 5 years of experience is required for a Senior Electronics Engineer and minimum 3 years of experience for Electronics Engineer. Minimum of 3 years of experience in the medical device field preferred for Senior Engineer and minimum 1 years of experience for Electronics Engineer. Skills Must be exceptionally good in C/C++ programming, testing/debugging and in advanced C concepts (pointers, structures, unions, interrupts etc.) Strong Knowledge of hardware design in Analog, high frequency Digital Circuit Design and RF circuits design Experience with I2C, SPI, UART, USB, Ethernet, BL/BLE On Micro-Controllers (preferably ARM) Good amount of core experience in the field of embedded systems design and programming or must have completed 6 months certified course in C programming/Embedded systems Must have completed a number of Embedded Systems based projects based on 8/16/32 bit microcontrollers preferably for medical equipments Good knowledge of using tools like C/C++ cross compilers for microcontrollers. (GCC/Keil/MCUExpresso) Driver development in Linux SBC environment preferable Experience with resource limited Embedded RTOS or Embedded Linux in SBC Proficient with PCB design tools or EDA Software (Altium or OrCAD) Experience Implementing and Testing Device Drivers for Linux/Win In C, Embedded C, C++ EMI/EMC and safety standards for medical equipments and test requirements Experience in DFMEA and Risk analysis and product development life cycle PHYSICAL REQUIREMENTS General Labor Environment requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additional Physical Requirements Requires travel based on business needs. Show more Show less

Requisition ID: 33262 At Terumo Blood and Cell Technologies, our 7,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. JOB TITLE: Factory Human Resources Manager Job Summary Working independently with global direction, provides leadership in the area of Human Resources. Takes the time to design, plan, and implements associate programs, processes, policies, and procedures to meet and support changing and ongoing business needs. Plays a crucial role in ensuring the effective recruitment, development, and retention of a skilled and motivated workforce. Delivers results for the full employee lifecycle to include organizational design, talent acquisition, benefits, compensation, learning & development, coaching, and career development. Essential Duties Accountable for overall management and day-to-day running of the Human Resource function, a customer group, and the associates who operate within the customer group. Collaborates with safety and compliance teams to ensure a safe working environment and compliance with relevant regulations. Listen to associates, attends meeting and collects feedback for maintaining a positive work environment by addressing employee concerns, conflicts, and grievances and developing training to close gaps. Develops and implements initiatives to enhance employee engagement, satisfaction, and retention. Organizes events and activities to foster a positive company culture. Leads projects, or segments of projects, assuring their integration within Human Resources, the business, and corporation, as appropriate. Provides guidance for professional development and succession planning of staff and associates. Makes recommendations to management regarding HR related initiatives, program changes, and effective cost reducing strategies. Provides expertise and coaching in areas that may have legal implications, including labor relations. Participates in organizational development ensuring that systems and resources are aligned to support long term business goals. Ensures that Human Resources participate at a peer level on major business initiatives, significantly influencing the design and outcome of non-HR business issues. Accountable for decisions with HR implications within the business or business segment, considering and ensuring appropriate process and linkages across businesses. Other Duties And Responsibilities May serve on various Business/Corporate committees dealing with topics such as benefits, policies, compensation, and reward systems. Minimum Qualification Requirements Education Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Experience Minimum 10 years proven experience in human resource management, preferably in a manufacturing or industrial setting.. Experience in design, planning, and implementation of innovative Human Resource and other business plans and programs. Strong understanding of labor laws, regulations, and compliance requirements. Skills Demonstrated ability to speak, write and communicate in English. Demonstrated ability to lead people and projects. Ability to demonstrate and establish collaborative working relationships with all levels within the organization in addition to working with external customers when necessary. Requires in-depth working knowledge and understanding of various areas of Human Resources such as Associate Relations, HRIS, Benefits, Compensation, and associate training and organizational development. Requires strong analytical skills, ability to identify, define, and solve problems rapidly, and to think and plan strategically. Strong understanding of labor laws, regulations, and compliance requirements. Ability to successfully manage within a highly matrixed environment. Requires an in-depth understanding of human motivation and the ability to influence decision making in all functions and levels of the organization. Requires an in-depth understanding, knowledge, and interpretive ability regarding policies and procedures and the ability to apply solutions creatively within or outside of guidelines. Strong understanding and knowledge of state and federal regulations/legislation in the Human Resources areas Requires general business knowledge. Requires rapid and thorough independent decision making and creative problem solving skills, as well as the ability to accept personal and departmental accountability for areas of responsibility. Knowledge and use of relevant PC software applications and skills to use them effectively. -Or- An equivalent competency level acquired through a variation of these qualifications may be considered. Certificates, Licenses, Registrations N/A Physical Requirements Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Terumo Penpol is part of Terumo Group and is headquartered in Thiruvananthapuram, Kerala. As India’s largest blood bag manufacturer, we provide a comprehensive range of blood collection, storage and processing solutions for blood centers, hospitals and therapeutic apheresis centers in India and abroad. Our high-quality products touch the lives of patients in over 80 countries across the world. True to our mission of contributing to society through healthcare, our award-winning Corporate Social Responsibility initiatives reinforce our organizational values and culture. Firmly rooted in core values collectively termed as the ‘Associate Spirit’, our work culture fosters an environment conducive to growth and continuous learning. People are our greatest asset, and we place as much importance in their professional development as in the research and development of our products.

JOB SUMMARY Under general direction and as a member of a scrum team, provides technical leadership in the development of software automation frameworks involving application of new technologies with significant technical risk. Develops automated software tests at all levels of the testing pyramid. Extends, enhances and maintains the software automation library and framework. ESSENTIAL DUTIES Defines software automation strategies and best practices. Maintains full software test automation suite, reusable software components and function libraries. Demonstrates solid computer science fundamentals such as design patterns, data structures, OOP and software design. Demonstrates expert level application of Source Code Management tools. Applies performance and security test techniques. Supports performance and security testing activities at the API/Interface level. Applies Continuous integration/ Continuous Delivery (CI/CD) techniques with chosen build pipeline tools. Effectively implements TDD techniques and creates build pipelines to support CI/CD. Develops and manages dynamic software test data creation. Organizes and controls the software testing process to help deliver high quality software. Provides technical support and mentoring to other team members. Troubleshoots environmental set-up issues related to software test automation. Approves Code/Test Reviews. Participates in all levels of testing as required. Drives discussions for determining appropriate level at which to test the implemented functionality. Demonstrates mastery of traditional white and black box software test techniques. OTHER DUTIES AND RESPONSIBILITIES Maintains general knowledge of industry and Company regulatory and software quality standards and applies this knowledge to the completion of all projects. Responsible for oversight of the SQA/testing activities within scrum team such as, ensuring requirements are in place and are testable, writes verification plans, targets and identifies release of tests or if a new test is required, and ensures success of the team supporting the process to execute tests. Ensures release of software, writes verification reporting, performs reliability assessments, deferred issue reporting, requirements traceability, readiness statement and review, and process verification. Familiarity with GMP/CRF Part 11/IEEE/ISO 9000 standards for software quality assurance, impact/risk analysis, and software traceability. Holds self and team accountable for adherence to Agile principles and practices. Demonstrates required competencies and grow in the Leadership Competency Model. MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor’s degree in Computer Science or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Experience Minimum 5 +years experience in an SDET role. Skills Proficient in object-oriented programming and applications/embedded software development .NET C# ,C++, Python, Typescript/Angular 8+, T-SQL. Proficient in testing at the API level using tools like RestAssured, Postman/Swagger and at System testing using tools like Cucumber and Selenium or Protractor. Demonstrated proactive and strong problem-solving skills. Scans the environment for new technical skills, knowledge, or capabilities that can benefit business or personal performance. Has a track record of exceeding goals successfully. Provides timely and helpful information to others across the organization. Handles and manages crises effectively. Deals constructively with problems that do not have clear solutions or outcomes. Relies on a mixture of analysis, wisdom, experience, and judgment when making decisions. -Or- An equivalent competency level acquired through a variation of these qualifications may be considered.

JOB SUMMARY Creates, manages, coordinates, and successfully executes plans to complete projects in support of business and technical initiatives. Adheres to Terumo BCT practices for project governance. Assists with evolution of the Terumo BCT project-management methodology and tools. Communicates important milestones and achievements as well as risks as they relate to projects. ESSENTIAL DUTIES • Creates and executes complex project plans, and revises them as appropriate for project needs. • Defines and manages projects of small to moderate scope. • Facilitates and coordinates project activities and tasks to execute the project plan. • Manages scope, schedule and cost within plan. • Ensures proper assignment and coordination of resources per plan. • Facilitates the definition of quality and risk, and manages the project accordingly. Resolves and/or escalates project-related issues in a timely fashion. • Tracks status and metrics on the project delivery and value; escalates to functional management upon identification of deviations (or potential deviations) from plan. • Effectively manages communications, expectations, and interactions with all departments and internal stakeholders. • Delivers informative, well-organized presentations on project status and selected project topics. • Effectively utilizes each team member to accomplish the project objectives. • Keeps track of lessons learned and shares those lessons with team members. • Facilitates project governance and maintains project-management documentation. • Contributes to departmental portfolio management. • Partners with various Managers to successfully implement projects. • Occasionally manages multiple projects simultaneously. • Participates as a member of a project team. For R&D PMO: • Ensures adherence to organizational policies and procedures including design controls and the product development process. MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor’s degree, preferably in a science or technical related field or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Experience • Minimum 5 years of full-time project management experience in a related field such as IT systems implementation, technical product development, or other discipline • Knowledge of and experience with project management disciplines, methodology and tools. • Successful completion of global projects involving stakeholders from multiple regions (North America, Latin America, Asia-Pacific, EMEA) strongly preferred. For R&D PMO: • Experience participating in a project-management role developing a medical device (design controls experience) in a regulated environment strongly preferred. Skills • Dedicated to quality customer service, with proactive response to stakeholder needs. • Demonstrated ability to integrate subject matter expert input to develop project plans from concept through commercialization for activities. • Ability and willingness to work on multiple projects at one time. • Demonstrated ability to effectively lead and manage project teams. • Demonstrated ability to develop and maintain the overall project vision and strategy while managing the tactical details and activities. • Demonstrated facilitation skills to effect project progress per plan. • Ability to manage conflicts; to read situations quickly; to lead by influence; to exploit opportunities; and to find common ground and get cooperation with minimum noise. • Demonstrated ability to communicate effectively both verbally and in writing. • Knowledge and use of relevant PC software applications and skills to use them effectively, including Microsoft Project schedules Certificates, Licenses, Registrations • Project Management Professional certification (or equivalent) preferred. -Or- An equivalent competency level acquired through a variation of these qualifications may be considered. PHYSICAL REQUIREMENTS Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Job Description : New products development and support sustenance activities for existing products using design control process. Hands on experience in functional and simulated use tests of medical devices, test methods, development and knowledge on maintenance of lab equipment, calibration is desirable. Understanding & good knowledge of various standards such as ISO 13485, ISO 14971, ISO 3826, ISO 10993, ISO 15223 etc. Ability to perform Gap assessment for standards and prepare equivalency reports. Experience in facing regulatory body audits on design control process would be beneficial, but not mandatory. Identify the problem and perform root cause analysis for failures. Knowledge in analysis using QC tools would be highly beneficial. Support Design verification activities with protocol and report preparation. Statistical analysis of data for investigating trends, patterns, and relationships using quantitative data. Preparation and periodic update of labels, drawings and specifications as and when necessary for both local and global sites. Working collaboratively with all stakeholders in Penpol operations team and from other R&D sites across the globe. Create and update standard operating procedures (SOP) employed in new product development. Support prototype, sample and design verification builds and coordinate activities with other departments including production, planning, procurement, stores, logistics etc. Good understanding of product life cycle management Software : AutoCAD, SOLIDWORKS, Minitab, CorelDRAW, MS office, Excel Qualification : Bachelor’s or Master’s degree in Engineering or Science Experience : 1-8 years in Medical device industry, preferably involved in design and development

Job Title : Engineer / Sr. Engineer - Research & Development (New product Development) Job Description : New products development and support sustenance activities for existing products using design control process. Hands on experience in functional and simulated use tests of medical devices, test methods, development and knowledge on maintenance of lab equipment, calibration is desirable. Understanding & good knowledge of various standards such as ISO 13485, ISO 14971, ISO 3826, ISO 10993, ISO 15223 etc. Ability to perform Gap assessment for standards and prepare equivalency reports. Experience in facing regulatory body audits on design control process would be beneficial, but not mandatory. Identify the problem and perform root cause analysis for failures. Knowledge in analysis using QC tools would be highly beneficial. Support Design verification activities with protocol and report preparation. Statistical analysis of data for investigating trends, patterns, and relationships using quantitative data. Preparation and periodic update of labels, drawings and specifications as and when necessary for both local and global sites. Working collaboratively with all stakeholders in Penpol operations team and from other R&D sites across the globe. Create and update standard operating procedures (SOP) employed in new product development. Support prototype, sample and design verification builds and coordinate activities with other departments including production, planning, procurement, stores, logistics etc. Good understanding of product life cycle management Software : AutoCAD, SOLIDWORKS, Minitab, CorelDRAW, MS office, Excel Qualification : Bachelor’s or Master’s degree in Engineering or Science Experience : 1-8 years in Medical device industry, preferably involved in design and development

Job Summary We are looking for a highly skilled and experienced Embedded Systems Engineer to join our dynamic team. In this role, he/ she will: Be responsible for Designing, developing, and maintaining embedded systems and software for medical devices. Work closely with cross-functional teams to ensure the successful integration of hardware and software components. Be responsible for optimizing system performance, ensuring reliability, and meeting project deadlines. Have a strong background in embedded systems, excellent problem-solving skills, and the ability to work independently as well as part of a team. Be expected to stay up to date with the latest industry trends and technologies and apply this knowledge to improve our products and processes. Independently conduct design change impact assessment, coordinate technical reviews of the changes, conduct failure analysis and potential risk impact assessment as part of a cross-functional Team. Essential Duties Translate user and business requirements into detailed product requirement specifications and design specifications. Apply design controls with extensive knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 for medical device development. Design and develop embedded systems and software for medical devices. Collaborate with cross-functional teams to integrate hardware and software components. Optimize system performance and ensure reliability. Troubleshoot and resolve issues related to embedded systems. Document design specifications, test procedures, and results. Stay current with industry trends and technologies. Participate in code reviews and provide constructive feedback. Mentor junior engineers and provide technical guidance. Contribute to the continuous improvement of development processes. Ensure compliance with industry standards and regulations. Manage project timelines and deliverables. Apply Six Sigma and Lean principles to enhance efficiency and minimize waste. Define integration and verification plans with experience in budgeting adequate resources and time for execution of the plans Create, maintain and release Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) Conduct Technical reviews to root cause issues, perform tradeoff analysis, document key design considerations for future reference Other Duties And Responsibilities Work direction responsibility may include technicians and junior engineers. May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues. May contribute to the establishment of business objectives, goals, budgets, and costs. Minimum Qualification Requirements Education Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Bachelor of Science degree or Master of Science degree in Engineering preferred. Experience Minimum 3 years of experience for Electronics Engineer. Preferable Minimum of 3 years of experience in the medical device field preferred for Senior Engineer and minimum 1 years of experience for Electronics Engineer. Skills Strong Knowledge of hardware design in Analog, high frequency Digital Circuit Design and RF circuits design Hardware design experience with I2C, SPI, CAN, UART, USB, Ethernet, BLE protocols on Micro-Controllers (preferably ARM) Must have completed a number of Embedded Systems based projects based on 8/16/32 bit microcontrollers preferably for medical equipments Experience with resource limited Embedded RTOS or Embedded Linux in SBC Proficient with PCB design tools or EDA Software (Altium or OrCAD) Proficient in hardware debugging of high frequency circuits digital circuits Develops hardware architecture and component selection based on equipment requirement Hardware Design consideration for EMI/EMC and ESD and safety standards for medical equipments and test requirements Strong knowledge for detailed design documentation of the hardware circuits on component level Experience in DFMEA and Risk analysis and product development life cycle Physical Requirements General Labor Environment requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additional Physical Requirements Requires travel based on business needs.

Senior Software Engineer Job Summary Under general direction, participates as high-level technical expert in design development, coding, testing, and debugging new software or significant enhancements to existing software for third party customers, project leads, and management. Works with technical staff to understand problems with software and develops specifications to resolve them. Develops and/or provides technical leadership in the development of software involving application of new technologies with significant technical risk. Essential Duties Act as high-level technical expert, addressing problems of systems integration, compatibility, and multiple platforms. Lead a large development team in the design of highly complex software systems for internal and external customers and is responsible for project completion as required. Designs, develops, operates and maintains software and firmware components and computing systems software to apply to, and integrate with engineering, scientific and manufacturing requirements. Independently design and develop new software products or major enhancements to existing software for internal and external customers. Provides functional and empirical analysis related to the design, development, and implementation of software operating systems, including, but not limited to, utility software, development software, and diagnostic software. Perform feasibility analysis on potential future projects to management. Performs and Approves code and test reviews. Exercise considerable latitude in determining technical objectives of assignment. Advances new techniques or advances the state-of-the-art. Demonstrates expert computer science fundamentals such as design patterns, data structures, OOP and software design. Mentors less-experienced software development staff. Defines software development best practices. Other Duties And Responsibilities Represent the organization as the prime technical contact on contracts and projects. Interact with senior external personnel on significant technical matters often requiring coordination between organizations. May act as team leader on complex projects. May participate in the development of test strategies, devices, and systems. Holds self and team accountable for adherence to Agile principles and practices. Minimum Qualification Requirements Education Bachelor’s degree in Computer Science or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Experience Minimum 6 years’ experience Must have experience with mission critical applications, preferably medical products or devices. Knowledge of regulatory requirements preferred. Skills Possess proficiency in object engineering and applications development using Embedded C++. Experience with modern C++ highly preferred (C++11/14/17) Must have knowledge of unit and component level testing preferably within the Catch framework using BDD style. Skilled in Developing technical solutions to complex problems which require the regular use of ingenuity and creativity. Ability to use object-oriented systems composed of objects that communicate with one another using explicitly designed interfaces, an (OO) methodologies. Experience with embedded operating systems and tools to build those such as Yocto and/or Buildroot. Conducts research in design, development, testing and utilization of electronic data processing hardware and software and/or electrical components, circuitry, processes, packaging and cabinetry for CPU's and peripheral equipment. Inter Process Communication (IPC) concepts Experience in cross compiler, Firmware development, board bring up activities. Good to have experience in RTOS, VxWorks, shell script, JSON, GIT HUB, Angular JS, Jira. Work beyond routine nature of tasks, utilizing specialized knowledge and technologies. Individual must be team-oriented with excellent attitude and vision. Knowledge and use of relevant PC software applications and skills to use them effectively. Demonstrated ability to communicate effectively both verbally and in writing. -Or- An equivalent competency level acquired through a variation of these qualifications may be considered. Physical Requirements Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

JOB SUMMARY Senior systems engineer translates the user needs and business needs into the specifications that drive design, implementation, testing of products that are used for collection of blood and blood components. Senior systems engineer will practice design controls in compliance with the quality management systems to deliver on products that are effective, safe and compliant. In this role you are expected to coordinate the design activities in collaboration with various stakeholders including mechanical, electrical, software, quality, manufacturing and commercial Teams. As a senior systems engineer you are expected to independently conduct design change impact assessment, coordinate technical reviews of the changes, conduct failure analysis and potential risk impact assessment as part of a cross-functional Team. ESSENTIAL DUTIES Translate user and business requirements into detailed product requirement specifications and design specifications. Apply design controls with extensive knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 for medical device development. Lead multidisciplinary design efforts to ensure seamless integration and timely delivery. Collaborate globally to integrate mechanical, electrical, and software components, achieving functional and reliability goals. Lead design changes to implement and enhance features for blood collection platforms, ensuring quality and regulatory compliance. Independently conduct technical reviews with stakeholders to meet project design objectives. Perform failure analyses to prioritize testing and ensure design completeness and product quality Communicate and collaborate effectively to align teams and streamline workflows. Support design transfer to enable successful commercialization of complex products. Use systems thinking to design complex platforms integrating equipment, software, and disposables. Apply knowledge of manufacturing processes tailored to diverse product types like electronics, mechanical design and plastics. Define and manage project scope to optimize resources and avoid scope creep. Lead defect management meetings to achieve actionable outcomes and maintain good documentation practices. Develop and approve test protocols to ensure functional testing and maximize reuse for multiple configurations. Apply Six Sigma and Lean principles to enhance efficiency and minimize waste. Define integration and verification plans with experience in budgeting adequate resources and time for execution of the plans Create, maintain and release Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) Conduct Technical reviews to root cause issues, perform tradeoff analysis, document key design considerations for future reference OTHER DUTIES AND RESPONSIBILITIES Work direction responsibility may include technicians and junior engineers. May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues. May contribute to the establishment of business objectives, goals, budgets, and costs. MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Bachelor of Science degree or Master of Science degree in Engineering preferred. Experience Minimum of 7-9 years of engineering experience is required for a Senior System Engineer and 5-7 years of experience for a System Engineer. Minimum of four years systems engineering experience in the medical device field preferred for Sr. Engineer and 2 years experience for System Engineer. Skills Proficient in configuration management for complex medical device platforms including hardware, software and disposables Knowledgeable in evaluating designs for serviceability and manufacturability Practice the creation, maintenance of Design History files for medical device products Awareness of EUMDR, FDA QSR for technical documentation, labeling and clinical evaluation Develop and oversee test methods to demonstrate the design has implemented the necessary functionality Conduct design analysis necessary to evaluate the completeness of specifications, testing Utilize failure analysis to determine if the designs are effective in meeting the user and business needs Evaluate the designs for serviceability and manufacturability Mentor junior engineers on the practice of systems thinking Manage projects independently to lead changes to existing features and incorporate new features for the product platforms used in collecting blood and blood components Experience in conducting risk analysis for defects to demonstrate the safety and efficacy of medical device platforms Proficient in using requirements management tools like Doors, Windchill RV&S Proficient in using test management tools like ALM for test case management Experience in using SysML for describing the complex design using tools like CATIA Magic Cyber Systems Engineer, PTC Modeler or Enterprise Architect. PHYSICAL REQUIREMENTS General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additional Physical Requirements Requires travel based on business needs.

JOB SUMMARY We are looking for a highly skilled and experienced Senior Embedded Systems Engineer to join our dynamic team. In this role, he/ she will: Be responsible for Designing, developing, and maintaining embedded systems and software for medical devices. Work closely with cross-functional teams to ensure the successful integration of hardware and software components. Be responsible for optimizing system performance, ensuring reliability, and meeting project deadlines. Have a strong background in embedded systems, excellent problem-solving skills, and the ability to work independently as well as part of a team. Be expected to stay up to date with the latest industry trends and technologies and apply this knowledge to improve our products and processes. Independently conduct design change impact assessment, coordinate technical reviews of the changes, conduct failure analysis and potential risk impact assessment as part of a cross-functional Team. ESSENTIAL DUTIES Translate user and business requirements into detailed product requirement specifications and design specifications. Apply design controls with extensive knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 for medical device development. Design and develop embedded systems and software for medical devices. Collaborate with cross-functional teams to integrate hardware and software components. Optimize system performance and ensure reliability. Troubleshoot and resolve issues related to embedded systems. Document design specifications, test procedures, and results. Stay current with industry trends and technologies. Participate in code reviews and provide constructive feedback. Mentor junior engineers and provide technical guidance. Contribute to the continuous improvement of development processes. Ensure compliance with industry standards and regulations. Manage project timelines and deliverables. Apply Six Sigma and Lean principles to enhance efficiency and minimize waste. Define integration and verification plans with experience in budgeting adequate resources and time for execution of the plans Create, maintain and release Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) Conduct Technical reviews to root cause issues, perform tradeoff analysis, document key design considerations for future reference OTHER DUTIES AND RESPONSIBILITIES Work direction responsibility may include technicians and junior engineers. May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues. May contribute to the establishment of business objectives, goals, budgets, and costs. MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Bachelor of Science degree or Master of Science degree in Engineering preferred. Experience Minimum of 5 years of experience is required for a Senior Electronics Engineer and minimum 3 years of experience for Electronics Engineer. Minimum of 3 years of experience in the medical device field preferred for Senior Engineer and minimum 1 years of experience for Electronics Engineer. Skills Must be exceptionally good in C/C++ programming, testing/debugging and in advanced C concepts (pointers, structures, unions, interrupts etc.) Strong Knowledge of hardware design in Analog, high frequency Digital Circuit Design and RF circuits design Experience with I2C, SPI, UART, USB, Ethernet, BL/BLE On Micro-Controllers (preferably ARM) Good amount of core experience in the field of embedded systems design and programming or must have completed 6 months certified course in C programming/Embedded systems Must have completed a number of Embedded Systems based projects based on 8/16/32 bit microcontrollers preferably for medical equipments Good knowledge of using tools like C/C++ cross compilers for microcontrollers. (GCC/Keil/MCUExpresso) Driver development in Linux SBC environment preferable Experience with resource limited Embedded RTOS or Embedded Linux in SBC Proficient with PCB design tools or EDA Software (Altium or OrCAD) Experience Implementing and Testing Device Drivers for Linux/Win In C, Embedded C, C++ EMI/EMC and safety standards for medical equipments and test requirements Experience in DFMEA and Risk analysis and product development life cycle PHYSICAL REQUIREMENTS General Labor Environment requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additional Physical Requirements Requires travel based on business needs.

ESSENTIAL DUTIES • Act as high-level technical expert, addressing problems of systems integration, compatibility, and multiple platforms. • Lead a large development team in the design of highly complex software systems for internal and external customers and is responsible for project completion as required. • Designs, develops, operates and maintains software and firmware components and computing systems software to apply to, and integrate with engineering, scientific and manufacturing requirements. • Independently design and develop new software products or major enhancements to existing software for internal and external customers. • Provides functional and empirical analysis related to the design, development, and implementation of software operating systems, including, but not limited to, utility software, development software, and diagnostic software. • Perform feasibility analysis on potential future projects to management. • Performs and Approves code and test reviews. • Exercise considerable latitude in determining technical objectives of assignment. Advances new techniques or advances the state-of-the-art. • Demonstrates expert computer science fundamentals such as design patterns, data structures, OOP and software design. • Mentors less-experienced software development staff. • Defines software development best practices. OTHER DUTIES AND RESPONSIBILITIES • Represent the organization as the prime technical contact on contracts and projects. Interact with senior external personnel on significant technical matters often requiring coordination between organizations. • May act as team leader on complex projects. • May participate in the development of test strategies, devices, and systems. • Holds self and team accountable for adherence to Agile principles and practices. MINIMUM QUALIFICATION REQUIREMENTS Bachelor’s degree in Computer Science or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Skills • Possess proficiency in object engineering and applications development using C++. Experience with modern C++ highly preferred (C++11/14/17) • Must have knowledge of unit and component level testing preferably within the Catch framework using BDD style. • Skilled in Developing technical solutions to complex problems which require the regular use of ingenuity and creativity. • Ability to use object-oriented systems composed of objects that communicate with one another using explicitly designed interfaces, an (OO) methodologies. • Experience with embedded operating systems and tools to build those such as Yocto and/or Buildroot. • Conducts research in design, development, testing and utilization of electronic data processing hardware and software and/or electrical components, circuitry, processes, packaging and cabinetry for CPU's and peripheral equipment. • Work beyond routine nature of tasks, utilizing specialized knowledge and technologies. • Individual must be team-oriented with excellent attitude and vision. • Knowledge and use of relevant PC software applications and skills to use them effectively. • Demonstrated ability to communicate effectively both verbally and in writing.

JOB SUMMARY This role leads technical excellence and drives innovation across the complete lifecycle of assigned product lines - from concept development through sustaining engineering to end-of-life. Through strong technical expertise and influential leadership, this role develops new approaches to product and process improvements, drives critical technical and strategy decisions, and leads project execution. The position guides cross-functional teams while ensuring reliable product technical integrity and delivering significant business impact through successful commercialization outcomes. ESSENTIAL DUTIES Lead technical strategy and product roadmap development for assigned product lines, driving innovative approaches to development and sustainment of key technologies Serve as the primary technical authority for assigned products, leading development initiatives and guiding investment decisions through technical expertise Drive technical program execution for development initiatives, making critical decisions that significantly impact product and business outcomes Lead product innovation through technical expertise and cross-functional influence, developing new approaches to cost reduction and performance enhancement Drive system architecture evolution and technical standards through functional team leadership, including development of new methodologies Lead quality and regulatory strategy implementation, developing new approaches to technical risk management for assigned products Communicate voice of customer and market needs to systems engineering, software and other functional partners to drive optimal product requirements Provide technical expertise and prioritization direction in support of sustaining activities. Balance the needs and priorities for field, factory and future for the product line. Provide technical leadership within project teams, developing new best practices and guiding others through expertise-based influence Guide complex product lifecycle decisions, driving continuous improvement through innovative approaches Guide design implementation and transfer activities, driving manufacturing partner alignment through technical leadership and innovative problem-solving Drive supplier technology advancement through technical leadership and strategic partnership development Foster cross-functional collaboration through technical influence and strategic decision making, delivering significant business impact Lead cross-functional collaboration through technical influence and strategic decision making, ensuring achievement of organizational objectives MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Advanced engineering degree strongly preferred. Experience Minimum 8 years progressive technical experience Minimum 3 years technical project leadership experience Minimum 3 years of product development experience in the medical device industry Demonstrated success leading product development phases from design through commercialization Strong experience in systems engineering and collaboration with software development teams Track record of driving results through cross-functional influence Proven success leading technical programs with significant organizational impact Skills Demonstrated ability to lead cross-functional development teams, with proven success driving significant business outcomes through technical innovation Strong business acumen with proven ability to shape product strategy through technical expertise and innovative approaches Excellent communication capabilities with demonstrated ability to influence technical and business stakeholders at all levels Technical leadership in product development processes, with proven ability to develop new methodologies and approaches Strong analytical and problem-solving capabilities, with demonstrated ability to devise novel solutions to complex technical challenges Proven expertise in project leadership including resource optimization and risk management of significant programs Comprehensive knowledge of medical device quality systems and regulatory requirements, with proven implementation success Strong background in technology assessment with demonstrated ability to drive innovation and new approaches Proven technical leadership with ability to guide and develop others through expertise and influence Demonstrated understanding of manufacturing processes with ability to drive significant improvements Track record of building strategic partnerships and driving alignment across organizational boundaries Expert proficiency with engineering tools and product development systems -Or- An equivalent competency level acquired through a variation of these qualifications may be considered. PHYSICAL REQUIREMENTS General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additional Physical Requirements May require domestic and international travel based on business need.

As a high-level technical expert, you will be responsible for addressing problems related to systems integration, compatibility, and multiple platforms. Leading a large development team, you will design highly complex software systems for internal and external customers, ensuring project completion as required. Your role will involve designing, developing, operating, and maintaining software and firmware components to meet engineering, scientific, and manufacturing requirements. You will independently design new software products or enhance existing ones, providing functional and empirical analysis for software operating systems. Performing feasibility analysis on potential projects and approving code and test reviews will be part of your responsibilities, allowing you considerable latitude in determining technical objectives. Demonstrating expertise in computer science fundamentals and mentoring junior staff, you will define software development best practices. Additionally, you will represent the organization as the prime technical contact on contracts and projects, interacting with senior external personnel on significant technical matters. As a team leader on complex projects, you may participate in the development of test strategies, devices, and systems. Holding yourself and your team accountable for adhering to Agile principles and practices will be crucial. A Bachelor's degree in Computer Science or equivalent education and experience is required for this role. Proficiency in object engineering and applications development using C++, particularly modern C++ (C++11/14/17), is essential. Knowledge of unit and component level testing within the Catch framework using BDD style is preferred. You should be skilled in developing technical solutions to complex problems, employing object-oriented systems and methodologies effectively. Experience with embedded operating systems like Yocto and/or Buildroot is necessary, along with conducting research in design, development, and testing of electronic data processing hardware and software. Utilizing specialized knowledge and technologies, you will go beyond routine tasks to contribute to the team's success. Your excellent team-oriented attitude and vision, along with effective communication skills, both verbal and written, will be essential for this role.,

We are searching for a highly skilled and experienced Senior Embedded Systems Engineer to become a part of our dynamic team. In this role, you will be responsible for designing, developing, and maintaining embedded systems and software for medical devices. Your key responsibilities will include working closely with cross-functional teams to ensure the successful integration of hardware and software components, optimizing system performance, ensuring reliability, and meeting project deadlines. You must possess a strong background in embedded systems, excellent problem-solving skills, and the ability to work independently as well as part of a team. It is expected of you to stay updated with the latest industry trends and technologies and apply this knowledge to enhance our products and processes. Additionally, you will independently conduct design change impact assessment, coordinate technical reviews of the changes, conduct failure analysis, and potential risk impact assessment as part of a cross-functional team. In your role, you will translate user and business requirements into detailed product requirement specifications and design specifications. You should apply design controls with extensive knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 for medical device development. Collaborating with cross-functional teams to integrate hardware and software components, optimizing system performance, ensuring reliability, and troubleshooting and resolving issues related to embedded systems are essential duties that you will perform. Documenting design specifications, test procedures, and results, staying current with industry trends and technologies, participating in code reviews, providing constructive feedback, mentoring junior engineers, and providing technical guidance are also part of your responsibilities. You will contribute to the continuous improvement of development processes, ensure compliance with industry standards and regulations, manage project timelines and deliverables, apply Six Sigma and Lean principles to enhance efficiency and minimize waste, define integration and verification plans, create, maintain and release Design History File (DHF), Device History Record (DHR), Device Master Record (DMR), and conduct technical reviews to root cause issues, perform tradeoff analysis, and document key design considerations for future reference. You may have work direction responsibility that includes technicians and junior engineers, work with manufacturing and other functional groups on manufacturing and regulatory compliance issues, and contribute to the establishment of business objectives, goals, budgets, and costs. The minimum qualification requirements include a bachelor's degree or equivalent education and experience sufficient to successfully perform the essential functions of the job, with a Bachelor of Science degree or Master of Science degree in Engineering preferred. A minimum of 5 years of experience is required for a Senior Electronics Engineer and a minimum of 3 years of experience for an Electronics Engineer, with a minimum of 3 years of experience in the medical device field preferred for Senior Engineer and a minimum of 1 year of experience for Electronics Engineer. Skills required for this role include exceptional proficiency in C/C++ programming, testing/debugging, and advanced C concepts (pointers, structures, unions, interrupts, etc.), strong knowledge of hardware design in Analog, high-frequency Digital Circuit Design, and RF circuits design, experience with I2C, SPI, UART, USB, Ethernet, BL/BLE on Micro-Controllers (preferably ARM), core experience in embedded systems design and programming, completion of Embedded Systems based projects based on 8/16/32 bit microcontrollers preferably for medical equipment, knowledge of using tools like C/C++ cross compilers for microcontrollers (GCC/Keil/MCUExpresso), driver development in Linux SBC environment preferable, experience with resource-limited Embedded RTOS or Embedded Linux in SBC, proficiency with PCB design tools or EDA Software (Altium or OrCAD), experience implementing and testing device drivers for Linux/Windows in C, Embedded C, C++, EMI/EMC, and safety standards for medical equipment and test requirements, experience in DFMEA and Risk analysis, and product development life cycle. The physical requirements for this role include working in a general labor environment that may require the use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds or transporting up to 500 pounds via carts or mechanized equipment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additionally, travel may be required based on business needs.,

As a high-level technical expert, you will be responsible for addressing problems related to systems integration, compatibility, and multiple platforms. You will lead a large development team in designing highly complex software systems for both internal and external customers, ensuring project completion as required. Your role will involve designing, developing, operating, and maintaining software and firmware components and computing systems software to meet engineering, scientific, and manufacturing requirements. Independently, you will design and develop new software products or major enhancements to existing software for internal and external customers. Additionally, you will provide functional and empirical analysis in relation to the design, development, and implementation of software operating systems, including utility software, development software, and diagnostic software. Feasibility analysis on potential future projects will also be within your scope of responsibility. In this role, you will have the authority to perform and approve code and test reviews, exercising considerable latitude in determining the technical objectives of assignments. You will be expected to advance new techniques and contribute to the state-of-the-art in computer science fundamentals such as design patterns, data structures, object-oriented programming, and software design. Furthermore, mentoring less-experienced software development staff and defining software development best practices will be key aspects of your responsibilities. Representing the organization as the prime technical contact on contracts and projects, you will interact with senior external personnel on significant technical matters that often require coordination between organizations. You may also act as a team leader on complex projects, participate in the development of test strategies, devices, and systems, and ensure adherence to Agile principles and practices for yourself and your team. To qualify for this role, you must hold a Bachelor's degree in Computer Science or possess an equivalent combination of education and experience. Proficiency in object engineering and applications development using C++ is essential, with experience in modern C++ (C++11/14/17) being highly preferred. Knowledge of unit and component level testing within the Catch framework using BDD style is required, along with the ability to develop technical solutions to complex problems creatively. Your experience with embedded operating systems and tools such as Yocto and/or Buildroot will be advantageous. Conducting research in design, development, testing, and utilization of electronic data processing hardware and software, as well as possessing a team-oriented attitude with excellent communication skills, are essential for success in this role.,