Stryker
Staff Software Quality Engineer, Post Market
Stryker, San Jose, California, United States, 95199
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
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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
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