Position Details
About this role
Lead verification efforts for medical device software, ensuring compliance with regulatory standards through manual and automated testing strategies.
Key Responsibilities
- Execute software verification
- Develop verification plans
- Partner with product teams
- Support risk management
- Implement automated testing
Technical Overview
Involves end-to-end software verification, developing verification plans, supporting risk management, and integrating automated tests into CI/CD pipelines within a regulated medical environment.
Ideal Candidate
The ideal candidate is a lead QA/test engineer with extensive experience in software verification within regulated medical device environments, familiar with FDA, ISO 13485, and IEC 62304 standards. They should have strong automation skills and experience supporting compliance and risk management.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience with medical device standards, No background in software verification, Inability to work with regulated environments, No automation experience
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