Terumo Penpol is a leading provider of medical devices, particularly known for manufacturing blood bag systems and medical products. The company focuses on providing innovative solutions for blood collection, transfusion, and related applications.
Trivandrum
INR 6.0 - 16.0 Lacs P.A.
Work from Office
Full Time
Experience Minimum 5+ years of experience in developing medical device software compliant with IEC 62304:2006 / AMD 1:2015 Software life cycle processes for medical devices standard. Development of software to a similar standard or level of rigor also acceptable (e.g. aerospace). Background in risk management processes, including FMEA (Failure Mode and Effects Analysis). Expertise in utilizing FMEA to analyze potential failure modes, prioritize risks, and develop robust mitigation strategies. Functional knowledge of ISO 14971:2019 Application of risk management to medical devices standard. Experience in defining and documenting system and subsystem requirements for complex systems and software solutions. Proficient in adhering to ISO/IEC/IEEE 29148:2018 Systems and software engineering standard to ensure comprehensive and structured requirements engineering. Expert in requirements traceability management tools to manage requirements and traceability between requirements, design elements, software test artifacts, interface controls, risk control measures, and outputs. Demonstrated success delivering large complex projects across the entire lifecycle. Skills • Attention to Detail: Meticulous attention to detail in all tasks and projects. • Behavioral Modeling: Consistently model exceptional behaviors, contributing to a positive and productive work environment and a culture of integrity and excellence. • Change Leader: Change leader who identifies opportunities for improvement and implements solutions to drive positive change. • Collaboration and Team Contribution: Skilled in fostering open communication and collaboration, encouraging input from others and contributing to a positive team environment. • Communication and Presentation: Clear communication and effective presentation skills, capable of delivering technical information to both technical and non-technical audiences and adept at responding to inquiries from various stakeholders. • Communication Skills: Superior written and verbal communication abilities, ensuring clear and effective communication of complex information across diverse audiences. • Critical Thinking: Apply critical thinking skills to analyze problems and develop innovative solutions. • Decision-making and Problem Solving: Proficient in identifying and resolving issues promptly. Make timely decisions involving appropriate stakeholders, ensuring efficient problem resolution and project execution . • Effective Communication: Proven ability to communicate effectively both verbally and in writing, fostering strong relationships and clear understanding. • Lab environment: Should not be sensitive to the sight or discussion of blood or needles. Both human and bovine blood is used where necessary, in addition to visiting customer sites where our equipment is used in a clinical or donor environment
Trivandrum
INR 9.0 - 16.0 Lacs P.A.
Work from Office
Full Time
MINIMUM QUALIFICATION REQUIREMENTS Education Bachelors 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 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 objective
Trivandrum
INR 7.5 - 11.0 Lacs P.A.
Work from Office
Full Time
JOB TITLE: Electronics Engineer 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 Experience • Minimum 3 years of experience for Electronics Engineer. • Preferable Minimum of 1 years of experience in the medical device field preferred for Electronics Engineer. Skills 1. Good Knowledge of hardware design in Analog, high frequency Digital Circuit Design and RF circuits design 2. Hardware design experience with I2C, SPI, CAN, UART, USB, Ethernet, BLE protocols on Micro- Controllers (preferably ARM) 3. Must have completed a number of Embedded Systems based projects based on 8/16/32 bit microcontrollers preferably for medical equipments 4. Experience with resource limited Embedded RTOS or Embedded Linux in SBC 5. Proficient with PCB design tools or EDA Software (Altium or OrCAD) 6. Proficient in hardware debugging of high frequency circuits digital circuits 7. Develops hardware architecture and component selection based on equipment requirement 8. Hardware Design consideration for EMI/EMC and ESD and safety standards for medical equipments and test requirements 9. Knowledge for detailed design documentation of the hardware circuits on component level
Thiruvananthapuram
INR 5.0 - 15.0 Lacs P.A.
Work from Office
Full Time
SYSTEM ENGINEERING 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. 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.
Thiruvananthapuram
INR 7.0 - 17.0 Lacs P.A.
Work from Office
Full Time
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 projectmanagement 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 projectrelated 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 MINIMUM QUALIFICATION REQUIREMENTS - Education Bachelors 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. 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.
Thiruvananthapuram
INR 6.5 - 15.0 Lacs P.A.
Work from Office
Full Time
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. 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. MINIMUM QUALIFICATION REQUIREMENTS Education Bachelors 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 4 years experience .
Thiruvananthapuram
INR 10.0 - 19.0 Lacs P.A.
Work from Office
Full Time
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 4 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.
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