Stryker · 1 day ago
Staff Software Quality Engineer, Post Market
Orlando, FL
Full-time
Hybrid
Senior Level, Lead/Staff
4+ years expStryker is hiring a Staff Software Quality Engineer, Post Market to support their Medical’s Digital Health division and portfolio Software as a Medical Device (SaMD). The role involves overseeing compliance, monitoring performance, and driving continuous improvement for software medical products after market release.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
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)
Qualification
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
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chief Executive Officer
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase