Software Quality Engineer, Post Market

Staff Software Quality Engineer, Post Market

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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. You will oversee ongoing compliance, monitor performance, and drive continuous improvement for both regulated and non‑regulated software medical products after market release.

This hybrid role requires commuting to one of the following locations:
San Jose, CA;
Orlando, FL;
Portage, MI; or Fort Wayne, IN. In‑office presence is required Monday–Wednesday; remote work is available Thursday and Friday.

• 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 (Sales Force/SAP/Trackwise/Jira/Windchill/Atlassian Suite/Zen Desk/Service Now).
• 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).

• 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.

• 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 Med Surg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Stryker impacts more than 150 million patients annually.

Seniority level:
Associate.

Employment type:

Full‑time.