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Senior Software Quality Engineer, Post Market

Stryker

Orlando, FL
Full Time
Senior
77k-161k
7 days ago

Job Description

About the Role

Stryker is hiring a Senior Software Quality Engineer, Post Market to support their Medical's Digital Health division and portfolio Software as a Medical Device (SaMD)/Software in a Medical Device (SiMD) and Software as a non-medical device (SaND). The role involves post-market activities to drive customer quality, ensuring regulatory compliance, and supporting customer outcomes through quality investigations, risk assessments, and process improvements. This hybrid position requires candidates to be within commuting distance of San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN, with a schedule that includes on-site work Monday through Wednesday and remote work Thursday and Friday.

Key Responsibilities

  • Support post-market quality activities by driving complaint investigations, NC/CAPA processes, and product field actions in collaboration with cross-functional teams.
  • Partner with Professional Services and Technical Support to ensure high-quality customer outcomes during software installations and support interactions.
  • Investigate, reproduce, and document customer-reported issues using tools like Salesforce, Jira, Trackwise, SAP, Windchill, and ServiceNow.
  • Conduct risk assessments and Health Hazard Analyses in partnership with R&D and Quality teams to ensure patient safety and regulatory compliance.
  • Collaborate with engineering and support teams to prioritize and resolve customer-facing bugs, contributing to root cause analysis and corrective actions.
  • Monitor and report on post-market KPIs, providing data analytics and insights for business reviews and continuous improvement initiatives.
  • Contribute to cybersecurity and data privacy incident responses in coordination with Legal, Compliance, and Product Security teams.
  • Participate in process improvement initiatives by applying software industry best practices and regulatory standards (e.g., FDA, HHS).

Requirements

  • Bachelor's degree in science or engineering.
  • Minimum of 2 years of experience as an Engineer.
  • Hands-on experience using Power BI or similar tools for data visualization and monitoring.
  • Working knowledge of QA practices, including defect tracking and risk-based testing, especially in post-market or production environments involving NC/CAPA processes.
  • 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) demonstrating strong technical aptitude and collaboration skills.

Nice to Have

  • Experience with risk-based testing and defect tracking in post-market environments.
  • Knowledge of FDA guidance on software classification.
  • Experience with cybersecurity and data privacy incident responses.

Qualifications

  • Bachelor's degree in science or engineering.
  • Minimum of 2 years of engineering experience.

Benefits & Perks

  • Salary range of $77,200 to $160,800 plus bonus and benefits.
  • Health benefits including medical, prescription drug, dental, vision, critical illness, accident, hospital indemnity insurance, and healthcare support programs.
  • Financial benefits such as HSA, FSA, 401(k), Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Working at Stryker

Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine that aim to improve patient and healthcare outcomes. The company values diversity and is an equal opportunity employer, considering applicants without regard to race, ethnicity, religion, sex, gender identity, sexual orientation, national origin, disability, or veteran status.

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Job Details

Posted AtJul 17, 2025
Job CategoryQA Engineering
Salary77k-161k
Job TypeFull Time
Work ModeRemote
ExperienceSenior

Job Skills

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About Stryker

Website

stryker.com

Location

Orlando, FL

Industry

Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers

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