Staff Engineer, Post Market Quality

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

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.

• Work on cybersecurity monitoring and data privacy related responses with Legal/Compliance/Product Security teams.

• 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.

What you need:

Required:

• Bachelor’s degree in science or engineering.

• Minimum of 4 years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D), Quality (QA/QC), or Regulatory Affairs (RA).

• Experience in software technical support resolution ensuring compliance with industry standards in handling Non-Conformances and Corrective Action and Preventative Action (NC/CAPA).

Preferred:

• Experience in software technical support resolution within the medical device industry, ensuring compliance with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and IEC 62304, including handling Non-Conformances and Corrective Action and Preventative Action (NC/CAPA).

• Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation.

• Experience with Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), supporting post-market activities to ensure compliance, drive customer quality, and address regulatory requirements, with proficiency in Salesforce, SAP, TrackWise, Jira, Windchill, Atlassian Suite, Zendesk, and ServiceNow.