Manager, Product Design Quality

Stryker is hiring a Manager, Product Design Quality to manage a team of Design Quality engineers that work on Software as a Medical Device (SiMD) or Software in a Medical Device (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, Portage, MI, 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 Software as a Medical Device (SiMD) and Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), and medical devices within Stryker Medical’s Digital Health portfolio.
• Collaborate with Marketing, Project Management Organization (PMO), and Research & Development (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 Design Failure Modes and Effects Analysis (dFMEA), Software Failure Modes and Effects Analysis (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 Regulatory Affairs and Quality Assurance (RAQA) goals, providing guidance, performance feedback, and career development opportunities.
  
  

What you need:

Required Qualifications:

• Bachelor’s degree in engineering.
• Minimum of 8 years’ experience working within the medical device or Medical Technology industries.
• Minimum of 1 year of experience leading teams within a highly regulated industry in following cGMP and GDP regulations.
• Experience in product design quality and software risk management, including Software Failure Modes and Effects Analysis (sFMEA) and design control processes (SAFe or Agile).
• Experience in software change management, release management, and defect management in using tools such as Jama, Confluence, DOORS, Enzyme, Bitbucket, Jira, or GitHub.
  
  

Preferred Qualifications:

• Experience with 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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.