Staff Software Quality Engineer, Post Market

Staff Software Quality Engineer, Post Market

Overview

Stryker is hiring a Staff Software Quality Engineer, Post Market to support our Medical’s Digital Health division and portfolio SaMD/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.

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.

Benefits

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.

Additional information

• Seniority level: Associate
• Employment type: Full-time
• Job function: Engineering and Information Technology
• Industries: Appliances, Electrical, and Electronics Manufacturing; Industrial Machinery Manufacturing; Medical Equipment Manufacturing