Quality Manager, Software Design Assurance

Work Flexibility: Hybrid or Onsite

Stryker is hiring a Quality Manager, Software Design Assurance 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 (SaMD) and Software in a Medical Device (SiMD) and other 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 to 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 Science, Engineering or related discipline.

• Minimum of 8 years’ experience working within the medical device or Technology industries.

• 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.

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.