Overview: Software Engineer-I will be involved in the development of software technologies for medical devices. The right candidate will be proactive, with great communication skills, demonstrate attention to details, have a passion for technology, and an excitement to produce great products. Software Engineer-I shall be responsible for the development of software projects associated with Spacelab’s product development activities. Personal development skills in requirements definition, design, implementation, and testing/debugging are essential. Participation in planning, requirements analysis, and coordination with leads, must be comfortable in all phases of the software development life cycle (SDLC),Willing to contribute to Integration testing and system test on need basis. Responsibilities: Adhere to Software development process and medical device standards (IEC 62304). Complete assigned tasks on time and in accordance with the appropriate process, including all QMS and regulatory requirements. Assist in defining and reviewing requirements and use cases. Find creative solutions from broadly defined problems or directives. Requirement’s analysis and generation. Configure, build, and test the application or technical architecture components. Fix any defects and performance problems discovered during testing. Cultivate and maintain knowledge of system integration and involve in integration test activities to find the integration issues and fix them. Good hands on with Integration and system tests and willing to participate. Ensure that all project tasks and deliverables conform to the appropriate processes and procedures. Ensure all software components unit/integration tested. Demonstrate ownership and responsibility for assigned tasks. Proactively communicate inside and outside the development team. Uphold Spacelabs values of Customer Obsession, Ownership Mindset and Superior Results. Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Good written and oral communication skills. Good documentation skills and software process discipline. Qualifications: Total Years of Experience: 4 + years. Significant Programming experience in C, C++ 11/14/17 Experience in Qt, QML. Hands-on object-oriented software design and development experience with a solid grasp of C++, data structures, algorithms, and design/UI patterns. Hands on experience in multithreading and Boost C++ libraries. Hands on experience in Linux. Experience in Azure DevOps and bug life cycle. Exceptional Debugging, Analytical and Problem-solving skills Collaborate with design engineers and clinical engineering team on translating product requirements into software design and create software specification documents. Experience is preferred in the medical device industry and good knowledge of FDA regulations. Scripting experience in Python and familiarity in working with Linux environment is desired. Working experience quickly to ramp-up on complex software components and ability to learn and deliver new languages/frameworks as required. Demonstrated experience in Design/Implementation for end-to-end medical device product development. B.E/B.Tech (M.E/M.Tech preferred) in the fields of ECE, CS or MCA degree. Certified Qt and QML Developer is a plus and C++ certification.
Overview: The Director of Research and Development is a highly motivated, technically savvy team builder who enjoys a fast-paced work environment, the freedom to establish a strategic vision and then execute on it and can obtain tangible results in a short period of time. A proven track record of success in medical device development is a must, with the expectation that the same success be obtained in this position. Responsibilities include managing the planning and execution of electromechanical product development, engineering staff development, and overall responsibility for ensuring that electromechanical development efforts are successful within a larger product development program. This role includes significant responsibility for managing and leading a remote site in India. Responsibilities: RESPONSIBILITIES: Engineering Activities: Plans and directs engineering activities with overall responsibility for the design and development of all electromechanical projects. Policy Compliance: Ensures all engineering projects, initiatives, and processes are in conformance with the organization's established policies and objectives. Product Development: Integral part of a product development organization that delivers market-leading medical products on time and under budget. Team Leadership: Builds, leads, manages, and coaches an engineering team of 60+. Remote Site Management: Manages and leads multi-site development activities, including a staff in India. Responsible for ensuring the remote site meets all KPIs on time and within budget. Ensures the site is integrated and well-represented. Innovation: Continuously seeks innovative ways to improve development productivity through the introduction of new technologies, systems, methods, and controls. Development Tools: Selects, implements, and trains engineering development tools. Stakeholder Collaboration: Works closely with other key stakeholders to define new products and ensure products meet or exceed customer requirements. Process Improvement: Establishes product development processes and metrics that effectively measure and improve team performance. Technology Trends: Monitors technological trends such as emerging standards and new technology opportunities. Resource Management: Engages requisite staff resources on a full-time or contract basis according to work level demands and budgetary constraints. Budgeting: Helps develop capital, operating, staffing, and project budgets; establishes annual department operating objectives and plans; and makes staffing and compensation decisions. Project Monitoring: Monitors project status, taking or approving corrective action as required in terms of schedules, budgets, priorities, staffing, and work quality. Competency Development: Ensures that engineering professionals are fully competent for their roles, effectively organized to deliver service to users, and receive appropriate training and mentoring. Core Values: Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork. Ethics and Conduct: Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. Ensure that direct report(s) are trained and evaluated on their knowledge and adherence to the Company’s values, Code of Ethics and Conduct, and applicable compliance policies. Quality Reporting: It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem. Flexibility: Duties may be modified or assigned at any time to meet the needs of the business. Leadership: Demonstrate open-mindedness and innovative thinking, empowering team members and fostering a collaborative culture. Represent a modern leadership style that is adept at guiding the new generation of engineers and leaders. Culture Building: Cultivate a transparent work environment that empowers and encourages personal and professional development with empathy. Budget Management: Develops research and development budget and manages expenses in line with organizational objectives; approves R&D expenditures including capital and manpower expenses. Team Creation: Creates and nurtures effective teams, effectively managing uncertainty and transitions, building and maintaining varied interpersonal connections, and engaging with senior management. Infrastructure Collaboration: Works with the infrastructure team to ensure the environment is available to support software and hardware development needs. Employee Engagement: Fosters employee engagement by actively promoting organizational diversity, nurturing a positive culture, and encouraging team-building activities. Functional Operations: Leads functional and departmental operations, overseeing talent planning, performance management, salary administration, and employee relations within the organization. Team Development: Coaches, mentors, and develops teams to enhance their effectiveness and boost employee engagement by fostering a collaborative and learning environment. Technology Analysis: Analyzes the external technology landscape to identify opportunities for the R&D team to collaborate with external partners or acquire technology that meets organizational needs. Project Lifecycle Management: Oversees the lifecycle of sustaining projects, ensuring they meet objectives and deliverables. Adaptability: Demonstrates adaptability and resilience to thrive in a dynamic and competitive environment. Flexible and agile in adjusting plans and priorities according to the changing needs and expectations of the market, customers, and organization. Continuous Learning: Constantly seeks to update and expand the knowledge and skills for self and team to stay relevant and competitive in the field. Problem Solving: Exhibits problem-solving skills and strategic planning to shape the organization’s direction. STRATEGIC LEADERSHIP: R&D Strategy: Develops and executes the overall R&D strategy, aligning it with the company's goals and identifying future research directions. R&D Management: Oversees all stages of the R&D lifecycle, ensuring projects are on time, within budget, and meet regulatory standards. Team Building: Leads and develops a high-performing team of scientists and researchers, fostering innovation and professional growth. Cross-functional Collaboration: Collaborates with various internal departments (Regulatory, Clinical, Marketing, etc.) and external partners. Regulatory and IP Oversight: Ensures compliance with regulations and manages the company's intellectual property strategy. Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrate behaviour consistent with the company’s Code of Ethics and Conduct. It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects for corrective action to be implemented and to avoid recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Qualifications: REQUIREMENTS: Education: Bachelor of Science in engineering/Biotechnology/Bio-Medical or equivalent with a minimum of 15+ years of medical product development experience. Management Experience: Minimum of 10 years prior engineering management experience with demonstrated ability to lead and manage people and teams. Regulatory Knowledge: Must be knowledgeable of FDA Design Control requirements. Vendor Management: Must have experience working with OEM vendors and outsourced development. Remote Management: Must have experience managing remote development activities. Change Catalyst: Must be comfortable and effective acting as a catalyst for change. Technical Skills: Must have experience in software, electrical, mechanical, and industrial design. Interpersonal Skills: Strong interpersonal skills, excellent formal and informal communication skills, innovative problem-solving skills, and strong facilitation skills are required. Performance Orientation: Candidate must be performance and results-oriented and be able to develop, motivate, and lead strong, effective teams. Remote Teams: Experience managing remote teams is desirable. Portfolio Management: Experience delivering a complex portfolio of products is desirable. Matrix Organization: Experience working in a matrix organization is desirable. Technical Requirements: Clearly outline the hardware, software, network, and security requirements for development. Physical Requirements : Standing: 10% Bending: Sitting: 80% Stooping: Reaching: Walking: 10% Lifting: (0 – 25lbs or 25 – 50lbs) It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented to avoid recurrence of the problem. NOTICE TO THIRD PARTY AGENCIES OSI Systems, Inc. and its subsidiaries (collectively “OSI”) does not accept unsolicited resumes from recruiters or employment agencies. If any person or entity, including a recruiter or agency, submits any information, including any resume or information regarding any potential candidate, without a signed agreement in place with OSI, OSI explicitly reserves the right to use such information, and pursue and/or hire such candidates, without any financial obligation to the person, recruiter or agency. Any unsolicited information or resumes, including those submitted directly to hiring managers, are considered and deemed to be the property of OSI. OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for the Security and Healthcare divisions, as well as to external original equipment manufacturer clients for application in the defense, aerospace, medical and industrial markets, among others. Acknowledgement I have read the job description and understand the requirements and expectations of this position. I will review orientation and training requirements with my manager. I understand that my duties may change, as directed by my manager.
Overview: JOB SUMMARY: The Quality Assurance Engineer shall provide leadership and support for QMS performance in many facets of business operations: Design Control To ensure the release of safe, effective and compliant medical devices, the Quality Assurance Engineer shall provide Quality System Design Control mentoring to ensure product design teams’ use of critical thinking. He or she shall be well versed in all aspects of Design Controls, Risk Management, Electrical Safety and all associated processes, policies, procedures, and records. He or she shall ensure that the proper activities are completed in a timely manner, performed and documented correctly, and readily offers guidance and support to ensure Quality System compliance. The Quality Assurance Engineer shall review all Engineering Change Orders and proposed changes or improvements to ensure sound engineering practice, effective and adequate design, product safety, and Quality System compliance. The Quality Assurance Engineer shall ensure that product Design Change activities move ahead in a timely and effective manner. Manufacturing The Quality Assurance Engineer shall monitor and ensure efficient and effective product manufacturing processes, facilitating adequate manufacturing work instructions, material control, nonconforming material handling, inspection, and finished goods handling. Material Review Board The Quality Assurance Engineer shall facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders. Process performance metrics shall be captured, monitored, and reported to ensure timely and effective MRB throughput and minimized quarantine back log. Installation and Service The Quality Assurance Engineer shall ensure that post-market activities ensure intended device performance. Service and support activities must be adequately documented, attention escalated to facilitate defect handling, and product performance and performance trends assessed to understand and drive improvement opportunities QMS Administration The Quality Assurance Engineers are responsible for conducting QMS administration activities, including Internal Quality Audits, Corrective and Preventive Action, Process Change Control, Exception Handling, process improvement and maintenance, supplier quality, external audit support, and related activities. Responsibilities: RESPONSIBILITIES and GOALS: The Quality Assurance Engineer shall follow the guidance of RA/QA Management and help other organizational functions understand and fulfill their obligations to meet quality objectives, systemic responsibilities, and customer requirements, as defined by Executive Management in the Spacelabs Quality Policy. As part of maintenance of the Spacelabs Quality Management System, Quality Assurance Engineers shall take part in some or all of the following responsibilities: Ensure high quality of products and services, by implementing and maintaining the Quality Management System. Ensure that QMS activities are risk-based. Perform, report, and drive remediation from Internal Quality Audits and participate in third party audit and inspection activities (MDR, MDSAP, etc.). Routinely pursue more efficient and effective operations (continual improvement). Support the development teams of all business areas, working within the project teams on new or sustaining product development projects. Support the maintenance of the Essential Requirements Checklists / General Safety, Essential Requirements checklist and Technical Documentation Files. Assist with the compliance to changes to standards such as EN 60601-1, ROHS3, REACH, and Global regulatory requirements applicable to Spacelabs’ products. Provide Quality System guidance to his or her product design teams. He or she shall be well versed in all aspects of Design Controls, Risk Management, Electrical Safety and all associated processes, policies, procedures, and records. Collaborate with engineering to determine and execute engineering design and development planning in support of regulatory submissions. Review Engineering Change Requests and Engineering Change Orders to identify critical components, defects in drawings/schematics, effective and adequate design documentation, product safety, and Quality System compliance. Assist with the creation, maintenance, and performance of QMS change management tools: Corrective Action Reports (CAR’s), Preventive Action Reports (PAR’s), and Process Change Orders (PCO’s). Support the manufacturing teams of all business areas, working within the teams on new or sustaining product and process improvements. Shall review and approve Device History Record (DHR) deliverables to ensure that production activities comply with Mandatory Device Master Record (DMR) requirements. Perform Manufacturing floor walkthroughs based on 7S criteria to support improvements and collaboration. Facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders. Create and update quality system procedure to achieve continuous compliance to ISO13485, European MDD/MDR, and MDSAP. Assist in the preparation and submittal of registration applications. May assist in the preparation of IDE, 510(k), CE Mark, and other similar regulatory filings. Shall participate in cross-functional design teams to review all Design and Development Plans, Design Inputs, Design Outputs, V&V documents, and Design Changes including Defect Reports. Quality Assurance Engineers shall recognize potential impacts to health or device efficacy (“Safety Issues”), support criticality assessment needed to ensure the application of reasonable and required Risk Management, Verification and Validation, and adequate record-keeping practices. Upholds the Company’s core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrates behavior consistent with the Company’s Code of Ethics and Conduct. Ensure that direct report(s) are trained and evaluated on their knowledge and adherence to the Company’s values, Code of Ethics and Conduct, and applicable compliance policies. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects for corrective action to be implemented and to avoid the recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Qualifications: Bachelor’s degree in a Quality, Engineering, or related discipline (Computer/Software, Biomedical, Mechanical, Electrical). 5+ years related Quality / Engineering work experience. 3+ years of experience with medical device regulatory and quality and Quality Management Systems Experience maintaining Technical Files, GSRPCs, Risk Management Files, Usability Engineering Files, Design History Files, MVP's, and Change Control documentation. Experience with statistical analysis Knowledge of Software within a device or Software as a Medical Device (SaMD). Experience working with teams under design controls and during new product development to follow the QMS and comply with current regulations and standards. Proven ability to communicate effectively with staff at all levels of the organization. Self-motivated and organized. Desirable Experience acting as a Change Agent Experience with FDA 21 cfr 820, 21 cfr 11, 21 cfr 806, MDD, MDR, MDSAP, EN ISO 13485, EN ISO 14971, IEC 62366-1, EN ISO 15223, EN ISO 20417, EN 62304, Cybersecurity, IEC 60601-1, ISO 27001 and 14001 preferred. Creative problem solving, flexibility, and good negotiation skills. Some travel may be necessary both domestic and international, less than 5%.
Overview: The Mechanical Engineer provides support for projects involving complex mechanical design and manufacture in the development of Spacelabs patient monitoring products. Responsibility includes design, testing, prototyping and simulation, and parts selection. The Mechanical Engineer must demonstrate the ability to be solutions-oriented, work hands-on, meet schedule goals, lead/be part of effective teams, and demonstrate take-charge qualities. Responsibilities: Execute complex designs in the following disciplines: plastic injection molding, vacuum forming, machining, casting, stamping and sheet metal. Apply theoretical calculation to design in areas such as thermodynamics, fluid flow, or structural analysis by testing mathematical models to validate the capabilities and parameters of the design and prove the prototype will do as design indicates. Optimize development of project/product by trade-offs of schedule, development cost, tooling cost, product cost, functionality, reliability, and manufacturability to meet the goals and objectives of the company. Rigorous adherence to company and quality procedures and requirements. Prepare product requirements. Provide technical reports and presentations. Actively appraise technology and product concepts to keep product lines competitive and moving toward excellence by attending seminars, reading related articles and talking to vendors. Schedule own development activities. Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Qualifications: Bachelor’s Degree in Mechanical Engineering; equivalent experience may be accepted; Master’s degree in Mechanical Engineering preferred Relevant mechanical design/test experience (e.g. min 5+ years for level 2, 8+ level 3 (Overall relevant experience determines level) such as: Experience designing medical products Experience using rapid prototyping devices Experience in SolidWorks and mechanical stress and thermal modeling Experience analyzing parts and assemblies in CAE applications, preferably CosmosWorks Knowledge of HALT and HASS Experience with design documentation process Ability to manage multiple, complex priorities within demanding timeframes. Strong problem-solving skills. Experience working positively and productively in a team environment. Must possess the ability to work effectively with internal and external resources as a part of the product development process. Strong communication skills, including excellent writing and presentation skills.
Overview: Software Engineer-I will be involved in the development of software technologies for medical devices. The right candidate will be proactive, with great communication skills, demonstrate attention to details, have a passion for technology, and an excitement to produce great products. Software Engineer-I shall be responsible for the development of software projects associated with Spacelab’s product development activities. Personal development skills in requirements definition, design, implementation, and testing/debugging are essential. Participation in planning, requirements analysis, and coordination with leads, must be comfortable in all phases of the software development life cycle (SDLC),Willing to contribute to Integration testing and system test on need basis. Responsibilities: Adhere to Software development process and medical device standards (IEC 62304). Complete assigned tasks on time and in accordance with the appropriate process, including all QMS and regulatory requirements. Assist in defining and reviewing requirements and use cases. Find creative solutions from broadly defined problems or directives. Requirement’s analysis and generation. Configure, build, and test the application or technical architecture components. Fix any defects and performance problems discovered during testing. Cultivate and maintain knowledge of system integration and involve in integration test activities to find the integration issues and fix them. Good hands on with Integration and system tests and willing to participate. Ensure that all project tasks and deliverables conform to the appropriate processes and procedures. Ensure all software components unit/integration tested. Demonstrate ownership and responsibility for assigned tasks. Proactively communicate inside and outside the development team. Uphold Spacelabs values of Customer Obsession, Ownership Mindset and Superior Results. Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Good written and oral communication skills. Good documentation skills and software process discipline. Qualifications: Total Years of Experience: 4 + years. Significant Programming experience in C, C++ 11/14/17 Experience in Qt, QML. Hands-on object-oriented software design and development experience with a solid grasp of C++, data structures, algorithms, and design/UI patterns. Hands on experience in multithreading and Boost C++ libraries. Hands on experience in Linux. Experience in Azure DevOps and bug life cycle. Exceptional Debugging, Analytical and Problem-solving skills Collaborate with design engineers and clinical engineering team on translating product requirements into software design and create software specification documents. Experience is preferred in the medical device industry and good knowledge of FDA regulations. Scripting experience in Python and familiarity in working with Linux environment is desired. Working experience quickly to ramp-up on complex software components and ability to learn and deliver new languages/frameworks as required. Demonstrated experience in Design/Implementation for end-to-end medical device product development. B.E/B.Tech (M.E/M.Tech preferred) in the fields of ECE, CS or MCA degree. Certified Qt and QML Developer is a plus and C++ certification.
Overview: JOB SUMMARY: The Quality Assurance Engineer shall provide leadership and support for QMS performance in many facets of business operations: Design Control To ensure the release of safe, effective and compliant medical devices, the Quality Assurance Engineer shall provide Quality System Design Control mentoring to ensure product design teams’ use of critical thinking. He or she shall be well versed in all aspects of Design Controls, Risk Management, Electrical Safety and all associated processes, policies, procedures, and records. He or she shall ensure that the proper activities are completed in a timely manner, performed and documented correctly, and readily offers guidance and support to ensure Quality System compliance. The Quality Assurance Engineer shall review all Engineering Change Orders and proposed changes or improvements to ensure sound engineering practice, effective and adequate design, product safety, and Quality System compliance. The Quality Assurance Engineer shall ensure that product Design Change activities move ahead in a timely and effective manner. Manufacturing The Quality Assurance Engineer shall monitor and ensure efficient and effective product manufacturing processes, facilitating adequate manufacturing work instructions, material control, nonconforming material handling, inspection, and finished goods handling. Material Review Board The Quality Assurance Engineer shall facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders. Process performance metrics shall be captured, monitored, and reported to ensure timely and effective MRB throughput and minimized quarantine back log. Installation and Service The Quality Assurance Engineer shall ensure that post-market activities ensure intended device performance. Service and support activities must be adequately documented, attention escalated to facilitate defect handling, and product performance and performance trends assessed to understand and drive improvement opportunities QMS Administration The Quality Assurance Engineers are responsible for conducting QMS administration activities, including Internal Quality Audits, Corrective and Preventive Action, Process Change Control, Exception Handling, process improvement and maintenance, supplier quality, external audit support, and related activities. Responsibilities: RESPONSIBILITIES and GOALS: The Quality Assurance Engineer shall follow the guidance of RA/QA Management and help other organizational functions understand and fulfill their obligations to meet quality objectives, systemic responsibilities, and customer requirements, as defined by Executive Management in the Spacelabs Quality Policy. As part of maintenance of the Spacelabs Quality Management System, Quality Assurance Engineers shall take part in some or all of the following responsibilities: Ensure high quality of products and services, by implementing and maintaining the Quality Management System. Ensure that QMS activities are risk-based. Perform, report, and drive remediation from Internal Quality Audits and participate in third party audit and inspection activities (MDR, MDSAP, etc.). Routinely pursue more efficient and effective operations (continual improvement). Support the development teams of all business areas, working within the project teams on new or sustaining product development projects. Support the maintenance of the Essential Requirements Checklists / General Safety, Essential Requirements checklist and Technical Documentation Files. Assist with the compliance to changes to standards such as EN 60601-1, ROHS3, REACH, and Global regulatory requirements applicable to Spacelabs’ products. Provide Quality System guidance to his or her product design teams. He or she shall be well versed in all aspects of Design Controls, Risk Management, Electrical Safety and all associated processes, policies, procedures, and records. Collaborate with engineering to determine and execute engineering design and development planning in support of regulatory submissions. Review Engineering Change Requests and Engineering Change Orders to identify critical components, defects in drawings/schematics, effective and adequate design documentation, product safety, and Quality System compliance. Assist with the creation, maintenance, and performance of QMS change management tools: Corrective Action Reports (CAR’s), Preventive Action Reports (PAR’s), and Process Change Orders (PCO’s). Support the manufacturing teams of all business areas, working within the teams on new or sustaining product and process improvements. Shall review and approve Device History Record (DHR) deliverables to ensure that production activities comply with Mandatory Device Master Record (DMR) requirements. Perform Manufacturing floor walkthroughs based on 7S criteria to support improvements and collaboration. Facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders. Create and update quality system procedure to achieve continuous compliance to ISO13485, European MDD/MDR, and MDSAP. Assist in the preparation and submittal of registration applications. May assist in the preparation of IDE, 510(k), CE Mark, and other similar regulatory filings. Shall participate in cross-functional design teams to review all Design and Development Plans, Design Inputs, Design Outputs, V&V documents, and Design Changes including Defect Reports. Quality Assurance Engineers shall recognize potential impacts to health or device efficacy (“Safety Issues”), support criticality assessment needed to ensure the application of reasonable and required Risk Management, Verification and Validation, and adequate record-keeping practices. Upholds the Company’s core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrates behavior consistent with the Company’s Code of Ethics and Conduct. Ensure that direct report(s) are trained and evaluated on their knowledge and adherence to the Company’s values, Code of Ethics and Conduct, and applicable compliance policies. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects for corrective action to be implemented and to avoid the recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. This role will work with R&D engineering 100% and therefore he/she has to have strong experience in following areas: Design Control, new product development Review and approve engineering changes representing Quality Working knowledge of ISO 13485 Maintain Design History File (DHF), Technical Files, Risk Management Experience with ISO 14971 Risk Management. Knowledge of Software with a Device or Software as a Medical Device Experience in Corrective and Preventive Action (CAPA) Experience in internal audits Qualifications: Bachelor’s degree in a Quality, Engineering, or related discipline (Computer/Software, Biomedical, Mechanical, Electrical). 5+ years related Quality / Engineering work experience. 3+ years of experience with medical device regulatory and quality and Quality Management Systems Experience maintaining Technical Files, GSRPCs, Risk Management Files, Usability Engineering Files, Design History Files, MVP's, and Change Control documentation. Experience with statistical analysis Knowledge of Software within a device or Software as a Medical Device (SaMD). Experience working with teams under design controls and during new product development to follow the QMS and comply with current regulations and standards. Proven ability to communicate effectively with staff at all levels of the organization. Self-motivated and organized. Desirable Experience acting as a Change Agent Experience with FDA 21 cfr 820, 21 cfr 11, 21 cfr 806, MDD, MDR, MDSAP, EN ISO 13485, EN ISO 14971, IEC 62366-1, EN ISO 15223, EN ISO 20417, EN 62304, Cybersecurity, IEC 60601-1, ISO 27001 and 14001 preferred. Creative problem solving, flexibility, and good negotiation skills. Some travel may be necessary both domestic and international, less than 5%.
Overview: Software Engineer-II will be involved in the development of software technologies for medical devices. The right candidate will be proactive, with great communication skills, demonstrate attention to details, have a passion for technology, and an excitement to produce great products. Software Engineer-II shall be responsible for the development of software projects associated with Spacelab’s product development activities. Personal development skills in requirements definition, design, implementation, and testing/debugging are essential. Participation in planning, requirements analysis, and coordination with leads, must be comfortable in all phases of the software development lifecycle (SDLC). Responsibilities: RESPONSIBILITIES: Adhere to Software development process and medical device standards (IEC 62304). Complete assigned tasks on time and in accordance with the appropriate process, including all QMS and regulatory requirements. Assist in defining and reviewing requirements and use cases. Find creative solutions from broadly defined problems or directives. Requirement’s analysis and generation. Configure, build, and test the application or technical architecture components. Fix any defects and performance problems discovered during testing. Cultivate and maintain knowledge of system integration. Ensure that all project tasks and deliverables conform to the appropriate processes and procedures. Ensure all software components unit/integration tested. Demonstrate ownership and responsibility for assigned tasks. Proactively communicate inside and outside the development team. Uphold Spacelabs values of Customer Obsession, Ownership Mindset and Superior Results. Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Good written and oral communication skills. Good documentation skills and software process discipline. Experience: Significant Programming experience in C, C++ 11/14/17 Experience in Qt, QML. Hands-on object-oriented software design and development experience with a solid grasp of C++, data structures, algorithms, and design/UI patterns. Handson experience in multithreading and Boost C++ libraries. Handson experience in Linux Experience in Azure DevOps Exceptional Debugging, Analytical and Problem-solving skills Collaborate with design engineers and clinical engineering team on translating product requirements into software design and create software specification documents. Experience is preferred in the medical device industry and good knowledge of FDA regulations. Scripting experience in Python and familiarity in working with Linux environment is desired. Working experience quickly to ramp-up on complex software components and ability to learn and deliver new languages/frameworks as required. Demonstrated experience in Design/Implementation for end-to-end medical device product development. Qualifications: Total Years of Experience: 6 + years B.E/B.Tech (M.E/M.Tech preferred) in the fields of ECE, CS or MCA degree. Certified Qt and QML Developer is a plus and C++ certification. OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.
Overview: The Mechanical Engineer provides support for projects involving complex mechanical design and manufacture in the development of Spacelabs patient monitoring products. Responsibility includes design, testing, prototyping and simulation, and parts selection. The Mechanical Engineer must demonstrate the ability to be solutions-oriented, work hands-on, meet schedule goals, lead/be part of effective teams, and demonstrate take-charge qualities. Responsibilities: Execute complex designs in the following disciplines: plastic injection molding, vacuum forming, machining, casting, stamping and sheet metal. Apply theoretical calculation to design in areas such as thermodynamics, fluid flow, or structural analysis by testing mathematical models to validate the capabilities and parameters of the design and prove the prototype will do as design indicates. Optimize development of project/product by trade-offs of schedule, development cost, tooling cost, product cost, functionality, reliability, and manufacturability to meet the goals and objectives of the company. Rigorous adherence to company and quality procedures and requirements. Prepare product requirements. Provide technical reports and presentations. Actively appraise technology and product concepts to keep product lines competitive and moving toward excellence by attending seminars, reading related articles and talking to vendors. Schedule own development activities. Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Qualifications: Bachelor’s Degree in Mechanical Engineering; equivalent experience may be accepted; Master’s degree in Mechanical Engineering preferred Relevant mechanical design/test experience (e.g. min 5+ years for level 2, 8+ level 3 (Overall relevant experience determines level) such as: Experience designing medical products Experience using rapid prototyping devices Experience in SolidWorks and mechanical stress and thermal modeling Experience analyzing parts and assemblies in CAE applications, preferably CosmosWorks Knowledge of HALT and HASS Experience with design documentation process Ability to manage multiple, complex priorities within demanding timeframes. Strong problem-solving skills. Experience working positively and productively in a team environment. Must possess the ability to work effectively with internal and external resources as a part of the product development process. Strong communication skills, including excellent writing and presentation skills.
Overview: Manage a team of Electrical and testing engineers, Mechanical engineers and product safety engineers, assigning tasks, providing technical guidance, and evaluating performance. Conduct performance reviews and provide mentor-ship to team members. Design and implement best-in-class systems for medical devices (such as patient monitoring, telemetry or anesthesia) and be part of a world class, highly energized engineering team. Responsibilities: The Hardware Development Manager is a highly motivated team builder and leader with a high amount of independent judgment and technical expertise. This position will also be required to manage assigned projects from initial concept development through completion, delivery and field follow up. Some project management responsibilities include new product development and maintenance of existing products as assigned. Plans and directs electrical engineering activities with overall responsibility for the design and development of all electrical subsystems. Ensures all engineering projects, initiatives, and processes are in conformance with organization's established policies and objectives. Integral part of a product development organization that delivers market leading medical products on time and under budget. Builds, leads, manages, and coaches an engineering team. Manages multi-site development activities Continuously seeks innovative ways to improve productivity development through the introduction of new technologies, systems, methods and controls. Selects, implements, and trains engineering development tools. Establishes PCBA product development processes and metrics that effectively measure and improve team performance. Monitors technological trends such as emerging standards and new technology opportunities. Engages requisite staff resources on a full-time or a contract basis according to work level demands and budgetary constraints. Helps develop capital, operating, staffing and project budgets; establishes annual Department operating objectives and plans; and makes staffing and compensation decisions. Monitors project status, taking or approving corrective action as required in terms of schedules, budgets, priorities, staffing, and work quality. Ensures that engineering professionals are fully competent for their roles, that they are effectively organized to deliver service to users, and that they receive appropriate training and mentoring. Negotiates between scheduled trade-offs and desirable product features with cross functional project teams. Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. Ensure that direct report(s) are trained and evaluated on their knowledge and adherence to the company’s values, Code of Ethics and Conduct, and applicable compliance policies. Manage, evaluate and develop team of employees to meet functional deliveries and responsibilities. Complete company people management requirements. Exhibit manager core competencies. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects for corrective action to be implemented and to avoid recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Qualifications: Experience : 15+ years of experience in Embedded Hardware digital & analog design, development, prototyping and manage the team. Medical Domain. Solid Works, Mechanical stress and thermal modeling. Knowledge of HALT and HASS. Analyzing parts and assemblies in CAE applications. Strong problem-solving skills. Requirements, Design solutions, creative and Innovation. Mentoring for Technical designs. Prepare block diagrams and good technical documentation skills. FMEA, Reliability analysis, and Environmental Standard requirements with design compliance for EMI/EMC. capable to establish and maintain strong PCBA development, test, and release practices. Must have experience developing both analog and digital circuitry. Must be knowledgeable of FDA Design Control requirements. Must be comfortable and effective acting as a catalyst for change. Educational Qualifications: Bachelor’s/master’s degree in electrical/mechanical engineering. Soft Skills: Excellent communication, interpersonal and leadership skills Good documentation skills Self-initiative and self-managed Voice out issues and persuasive to resolve issues Good time management and organizational skills An ability to work to deadlines PHYSICAL REQUIREMENTS: Standing: 15% Bending: <10% Sitting: 70% Stooping: < 10% Reaching: <10% Walking: 10% Lifting: (0 – 25lbs) < 5% Use of computer: 70% Must be able to complete job responsibilities working with global time zone needs such as attending late night/early morning meetings by phone and/or web to meet global business needs: 5%
Overview: The Cybersecurity Test Engineer II primary role is to identify and verify cybersecurity vulnerabilities and testing and verifying cybersecurity patches to be applied to Spacelabs Products. The Cybersecurity Test Engineer works as a key contributor to the Cybersecurity Team. Additionally this role participates in the Cybersecurity Team in responding to Sales Questionnaires. Responsibilities: Perform cybersecurity testing vulnerability and penetration testing under supervision. Documents targets, test plan, scenarios tested, findings, test evidence and recommendations in Cybersecurity test reports. Simulate tactics, techniques and procedures used by advanced cyber threat actors (i.e., “Hackers”). Leverage internal and external resources to research threats, vulnerabilities and intelligence on various attackers and attack infrastructure. Recognize and safely utilize attacker tools, tactics, and procedures Evaluates cybersecurity tools used in exploit development Provides assistance in security awareness and training activity Support Product Investigations for complaints and incidents Participates and sometimes leads the Sales Questionnaire Responses for cybersecurity. Participates as an active Cybersecurity team member in requirement reviews and team meetings. Analyze and review vulnerabilities and/or weaknesses identified by customer complaints. Participate in management technical reviews on test activities, scenarios, and results. Follows corporate standards and procedures Collaborates and shares knowledge with team members via formal and informal methods on a regular basis Provide regular assessment progress updates that include sufficient detail to convey work completed and upcoming activities Participates as an active Spacelab Cybersecurity team member in requirement reviews and team meetings Networking/Key relationships Will interface on a regular basis with groups across the organization as needed. Skills & Capabilities: Domain Expertise Knowlege/experience and understanding of firmware, operating systems, applications, networks and network protocols, encryption algorithms, Access Control Models Knowledge/experience and understanding of Software and Hardware engineering, reverse engineering, web applications, databases, scripting, Some knowledge in Operating Systems (Linux, MS Windows) Databases (MS SQL, MySQL, Postgres), Application/Web Servers (Apache, IIS, Wildfly), Microsoft WSUS Some knowledge/experience in Networking, including switching, routing, firewalls and vulnerabilities Security Testing Tools such but not limited to - Tenable Nessus, Rapid7 InsightVM, Metasploit, BurpSuite, NetSparker, Wireshark) Must have the ability to handle many software exploits and take ownership for the assigned security assessments Must have the ability to take ownership for high complexity Security Assessments. Ability to operate Spacelabs Medical Devices and Solutions. Knowledge of Secure Coding and Development including OWASP Top 10 and MITRE/SANS Top 25 Secure Software Development Life Cycle Security Frameworks (ISO 2700x, NIST Special Publications) Static Code Analysis Cloud Development and Cloud Security Testing Understand medical device regulations and quality system requirements Familiarity with some common attacks: Password Cracking Cross site request forgery Cross site scripting Improper Authorization Improper Authentication Privilege Escalation Agile/Digital Experience Passionate about Agile software processes, data-driven development, reliability, and experimentation Openness to working on a collaborative, cross-functional Agile solution team Qualifications: Minimum of 5 years of related experience Any Bachelors degree Individual Skills: Self-motivated with strong problem-solving and learning skills Professional attitude and service orientation; team player Flexibility to changes in work direction as the project develops Good verbal and written communication and listening skills Ability to work well with others and under pressure Strong analytical and critical observation skills Mindset and Behaviors: Team player that works collaboratively across Spacelabs. Passion for discovering and researching new vulnerabilities and exploitation techniques Strong work ethic; ability to work at an abstract level and gain consensus Able to build a sense of trust and rapport that creates a comfortable and effective workplace Attitude to thrive in a fast-paced environment Open minded to new approaches of learning Takes ownership and responsibility for data work
Overview: JOB SUMMARY: At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients. Why work at Spacelabs? Because lives depend on you! We are looking for an experienced and driven Senior Cybersecurity Analyst who is looking to put their cybersecurity, software engineering, audit and compliance experience, technical expertise knowledge to execute and deliver on existing and strategic compliance activities related to Spacelabs' cloud and medical device product compliance. As a Senior Cybersecurity Analyst, you will play a key role in continuing to build and maintain scalable and efficient processes related to control assessments with auditors, control remediation, and continuous monitoring. You will also be responsible for monitoring any changes to regulatory and industry standards security requirements. You will work with all functions of this rapidly evolving business whose products save lives. You will work directly with key stakeholders to drive continuous improvement, communication, and education with Spacelabs' internal and external customers. The right person will be excellent at communicating vertically and horizontally across the company and will be comfortable explaining Spacelabs' compliance posture to both internal and external customers, auditors, and providing technical and creative guidance to technical teams. Responsibilities: Cybersecurity Program: Collaborate with our partners, Government Accreditors, Sales Team, and Accreditors to effectively communicate our compliance position and program. Build relevant management dashboards and actively contribute technical expertise to compliance reporting and analyses. Identify potential compliance gaps and lead work streams needed to address them. Participate in security risk management process and maintain our cloud risk register. Coordinate cybersecurity projects and with other R&D and QA/RA Projects. Periodically provide project updates and security compliance/risk health scorecards to key stakeholders in a timely fashion. Drive improvements in existing processes and develop new innovative and efficient solutions. Communicate gaps to cybersecurity management and coordinate with cross functional team meetings to remediate and close control gaps. Build relationships with internal and external stakeholders. Accurately and effectively communicate our compliance position and programs to customers. Support privacy initiatives (such as HIPAA, GDPR) Lead efforts to respond to customer or sales inquiries related to cyber security capabilities associated with our products. Work to develop standard collateral that describes the cyber security capabilities and optimum implementation guidelines to ensure products are secure. Product Security Program: Prepare and document local Standard Operating Procedures (SOP) and protocols to help ensure the continued security by supporting and used Ensure that defined processes address effective and efficient integration of cyber security engineering with engineering design and Quality control functions. A in management of security-related risks, including reporting on outcomes and proposing further security improvements. Lead efforts to respond to customer or sales inquiries related to cyber security capabilities associated with our products. Work to develop standard collateral that describes the cyber security capabilities and optimum implementation guidelines to ensure products are secure. Coordinate customer technical reviews, and/or requests for technical assessments. Coordinate customer communications with legal, marketing, service, and sales related to cyber security announcements. Prepare and document standard operating procedures and protocols to help ensure the security of our products as they are designed, developed, supported, and used. Mentor the cybersecurity team members. All other duties as assigned. Qualifications: Who You Are? 10+ years’ experience in an equivalent technology risk and compliance related role and manage upto 3-4 members team Extensive knowledge and experience with security certification and accredition programs. Strong experience working with cybersecurity and privacy regulatory compliance/audit initiatives. Subject Matter Expert cybersecurity, privacy and cloud computing and the acronyms that come with it - Amazon Web Services (AWS), SaaS, IaaS, PaaS, etc. Knowledgeable about software development processes and SW development tools such as JIRA, Confluence, Azure DevOPs. Team Player who can demonstrate the ability to collaborate both internally and externally. Excellent written, verbal communication and presentation skills. Find creative solutions from broadly defined problems or directives. Willingness to wear different hats and work on areas where needed. Amazing organizational skills with a drive to succeed in a fast-paced environment. Demonstrate ability to work as part of a team and independently. Demonstrate ability to performing under pressure when working to tight deadlines. Able to calmly coordinate activities when working under short turnaround times. Experience performing Project Management responsibilities to plan and track execution of assigned workload. Ensure that all project tasks and deliverables conform to the appropriate processes and procedures. Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. Ability to hustle, get stuff done, and has strong integrity - make mom proud! Position will require working evening hours (support morning hours of Pacific Standard Time). Duties may be modified or assigned at any time to meet the needs of the business. Big audit firm Experience or Management Consulting Experience preferred. CISA, CISM, CIA, CISSP or other related certifications a plus. Cybersecurity, Information Security and/or Privacy certification. Project Management Certification. Experience in working in a healthcare delivery organization or a medical device manufacturer is desirable.