Principal Software Quality Engineer, Digital Health
USA-Medtronic MiniMed, Inc 1017
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Job summary
MiniMed in Los Angeles, CA seeks a Principal Software Quality Engineer to lead software quality activities for digital health solutions across mobile, web and cloud platforms. You will guide quality strategies within Agile/Waterfall/DevOps contexts, ensuring full traceability and regulatory compliance.
The role requires deep experience in medical device software, risk management, and CAPA execution, with collaboration across R&D, regulatory, and DevOps teams.
Qualifications
- Bachelor’s degree required with 7+ years in Quality, Engineering, or Software.
- Knowledge of ISO 13485, IEC 62304, HIPAA, FDA QMSR.
- Experience with SDLC in regulated medical devices.
- CQE/CSQE certification preferred.
Responsibilities
- Lead quality into design and development of digital health solutions including medical mobile device applications, web apps, and cloud technologies.
- Oversee software lifecycle activities and design reviews with full requirement traceability.
- Lead risk management activities including software FMEAs; triage issues with cross-functional teams.
- Develop and maintain software quality standards and operating methods across projects.
- Lead CAPA projects and regulatory audits; ensure compliant processes and documentation.
- Support post-market activities and regulatory reviews as needed.
Skills
Education
Tools
Job description
MiniMed in Los Angeles, CA seeks a Principal Software Quality Engineer to lead software quality activities for digital health solutions across mobile, web and cloud platforms. You will guide quality strategies within Agile/Waterfall/DevOps contexts, ensuring full traceability and regulatory compliance.
The role requires deep experience in medical device software, risk management, and CAPA execution, with collaboration across R&D, regulatory, and DevOps teams.
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