Staff Software Quality Engineer, Post Market

Stryker is hiring a Staff 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 non-medical device software to support projects as a quality engineer for post-market activities to drive customer quality. You will oversee ongoing compliance, monitor performance, and drive continuous improvement for both regulated and non-regulated software medical products after market release.

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; Orlando, FL; Portage, 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.

What you will do:

• Collaboratively ensure compliance with Quality Management System requirements for post-market activities, driving NC/CAPA, and PFA processes in partnership with the business.

• Partner with the Professional Services and Technical Support Organization to ensure quality customer outcomes through software solution installation and tech support activities and processes.  

• Drive and complete complaint investigations including follow-up with customers and internal cross functional stakeholders while using enterprise tools (SalesForce/SAP/Trackwise/Jira/Windchill/Atlassian Suite/ZenDesk/ServiceNow).

• Conduct risk assessments and Health Hazard Analysis as required in conjunction with R&D and Quality.

• Work on process improvement projects while applying software industry practices, compliance standards and guidance (FDA/HHS).

• Act as a subject matter expert on all related procedures, ensuring compliance to the relevant procedures.

• Support cybersecurity and data privacy efforts in collaboration with Legal, Compliance, and Product Security teams, addressing monitoring activities and regulatory responses. Oversee and track post-market KPIs for MDR, business reviews, and continuous process improvement, providing data analytics, KPI insights, and project status updates in business and management reviews.

• Develop and implement a QMS for non-medical devices to ensure product quality, efficient processes, and compliance with industry standards (e.g., ISO 9001).

What you need:

Required:

• Bachelor’s degree in science or engineering.
• Minimum of 4 years of experience as an Engineer
• Working knowledge of QA practices, including defect tracking and risk-based testing, especially in post-market or production environments involving NC/CAPA processes.
• Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation. Knowledge of software development life cycle (SDLC), software validation, and agile methodologies.

Preferred:

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

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.