• Senior Software Quality Engineer, Post Market

    Stryker (Kalamazoo, MI)


    **Stryker** is hiring a **Senior** **Software Quality Engineer, Post Market** to support our Medical’s Digital Health division and portfolio Software as a Medical Device (SaMD)/Software in a Medical Device (SiMD) and Software as a non-medical device (SaND) to support projects as a quality engineer for post-market activities to drive customer quality.

    Workplace Flexibility & Location:

    This hybrid role requires candidates to be within commuting distance of one of the following locations: **San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN** . The standard schedule includes on-site work Monday through Wednesday, with remote work on Thursday and Friday. Candidates must be able to commute to their designated facility as needed.

    What you will do:

    + Support post-market quality activities by driving complaint investigations, NC/CAPA processes, and product field actions in collaboration with cross-functional teams.

    + Partner with Professional Services and Technical Support to ensure high-quality customer outcomes during software installations and support interactions.

    + Investigate, reproduce, and document customer-reported issues using tools like Salesforce, Jira, Trackwise, SAP, Windchill, and ServiceNow.

    + Conduct risk assessments and Health Hazard Analyses in partnership with R&D and Quality teams to ensure patient safety and regulatory compliance.

    + Collaborate with engineering and support teams to prioritize and resolve customer-facing bugs, contributing to root cause analysis and corrective actions.

    + Monitor and report on post-market KPIs, providing data analytics and insights for business reviews and continuous improvement initiatives.

    + Contribute to cybersecurity and data privacy incident responses in coordination with Legal, Compliance, and Product Security teams.

    + Participate in process improvement initiatives by applying software industry best practices and regulatory standards (e.g., FDA, HHS).

    What you need:

    Required:

    + Bachelor’s degree in science or engineering.

    + Minimum of 2 years of experience as an Engineer

    Preferred:

    + Hands-on experience using **Power BI** or similar tools for basic data visualization and monitoring.

    + Working knowledge of **QA practices** , including defect tracking and **risk-based testing** , especially in post-market or production environments involving **NC/CAPA** processes.

    + Exposure to **Software as a Medical Device (SaMD)** , **Software in a Medical Device (SiMD)** , or **Software as a Non-Medical Device (SaND)** , with a general understanding of **FDA guidance** on software classification.

    + Internship or early-career experience at a leading tech company (e.g., **Amazon, Google, Microsoft** ) or similar, demonstrating strong technical aptitude and collaboration skills.

     

    77,200.00 to 160,800.00 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.

     

    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.