Manager, Product Design Quality
Stryker is hiring a Manager, Product Design Quality to manage a team of Design Quality engineers that work on SaMD/SiMD for our Digital Health solutions for our Medical division for pre-market new product development projects.?
Workplace Flexibility & Location requirements: This is a hybrid role requiring the candidate to be within commuting distance of one of the following locations: San Jose, CA, Kalamazoo, MI or Fort Wayne, IN. The work schedule is structured to support flexibility, with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be able to commute to one of these specific facilities as needed. Relocation assistance is approved for eligible candidates.
What you will do:
? Manage and develop a team of design quality engineers supporting SiMD and SaMD products within Medical's Digital Health portfolio.
? Collaborate with Marketing, PMO, and R&D to drive product quality prioritize projects, allocate resources, and make strategic decisions that enhance product quality.
? Oversee product development, verification, validation, risk management, and product security to ensure compliance while driving continuous process improvements.
? Lead and manage risk management activities (dFMEA/sFMEA, risk documents, product security, privacy) and approve quality documentation per QMS requirements.
? Track, monitor & report of the design and development of quality metrics, providing updates in management reviews as needed.
? Lead and support internal & external audits and regulatory compliance, drive actions on findings, and partner with Regulatory Affairs to meet global compliance requirements (FDA, EU, EMEA, APAC).
? Recruit, develop, train, and mentor top talent while fostering growth, engagement, and development through assignments and coaching.
? Define team objectives in alignment with business and RAQA goals, providing guidance, performance feedback, and career development opportunities.
What you need:
Required Qualifications:
? Bachelors degree in an Engineering discipline.
? Minimum 8+ years? of professional experience working within the Medical device industry.
? Minimum of 1-3 years of experience leading teams within a highly regulated and matrixed environment with product design quality.
? Expertise in software risk management (sFMEA, ISO 14971), design control processes (SAFe, Agile), and proficiency in software change, release, and defect management tools (e.g., Jama, Confluence, Doors, Enzyme, Bitbucket, Jira, GitHub).
Preferred Qualifications:
? Experience and knowledge of US and International Medical Device Regulations (820/IEC 62304/IEC 82304/60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions.
? Experience in participating in both internal and external audits, including direct interaction with regulatory agencies such as the FDA, MoH, and TUV.
? Experience with software technologies for mobile, cloud, or AI/ML solutions (e.g., AWS, Azure, Apple, Android) and their applications in Telehealth, Healthcare IT, or Virtual Nursing solutions.
115,600.00 to 245,800.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
Apply Now
Workplace Flexibility & Location requirements: This is a hybrid role requiring the candidate to be within commuting distance of one of the following locations: San Jose, CA, Kalamazoo, MI or Fort Wayne, IN. The work schedule is structured to support flexibility, with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be able to commute to one of these specific facilities as needed. Relocation assistance is approved for eligible candidates.
What you will do:
? Manage and develop a team of design quality engineers supporting SiMD and SaMD products within Medical's Digital Health portfolio.
? Collaborate with Marketing, PMO, and R&D to drive product quality prioritize projects, allocate resources, and make strategic decisions that enhance product quality.
? Oversee product development, verification, validation, risk management, and product security to ensure compliance while driving continuous process improvements.
? Lead and manage risk management activities (dFMEA/sFMEA, risk documents, product security, privacy) and approve quality documentation per QMS requirements.
? Track, monitor & report of the design and development of quality metrics, providing updates in management reviews as needed.
? Lead and support internal & external audits and regulatory compliance, drive actions on findings, and partner with Regulatory Affairs to meet global compliance requirements (FDA, EU, EMEA, APAC).
? Recruit, develop, train, and mentor top talent while fostering growth, engagement, and development through assignments and coaching.
? Define team objectives in alignment with business and RAQA goals, providing guidance, performance feedback, and career development opportunities.
What you need:
Required Qualifications:
? Bachelors degree in an Engineering discipline.
? Minimum 8+ years? of professional experience working within the Medical device industry.
? Minimum of 1-3 years of experience leading teams within a highly regulated and matrixed environment with product design quality.
? Expertise in software risk management (sFMEA, ISO 14971), design control processes (SAFe, Agile), and proficiency in software change, release, and defect management tools (e.g., Jama, Confluence, Doors, Enzyme, Bitbucket, Jira, GitHub).
Preferred Qualifications:
? Experience and knowledge of US and International Medical Device Regulations (820/IEC 62304/IEC 82304/60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions.
? Experience in participating in both internal and external audits, including direct interaction with regulatory agencies such as the FDA, MoH, and TUV.
? Experience with software technologies for mobile, cloud, or AI/ML solutions (e.g., AWS, Azure, Apple, Android) and their applications in Telehealth, Healthcare IT, or Virtual Nursing solutions.
115,600.00 to 245,800.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
Apply Now