Hybrid Lead Software Quality Engineer, Digital Health
USA-MiniMed Distribution Corp. 1018
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Job summary
MiniMed is seeking a Principal Software Quality Engineer to lead quality efforts for digital health products including mobile apps, web apps, and cloud solutions. Hybrid role based in Northridge, CA, combining R&D collaboration with quality governance across Agile/Waterfall/DevOps processes.
You will drive design reviews, risk analysis, CAPA projects, and regulatory alignment with ISO 13485, IEC 62304, HIPAA, and FDA QMSR requirements, while supporting internal and external audits and
Qualifications
- Bachelor's degree in engineering, science, or technical field with 7+ years of relevant experience.
- Advanced Degree in engineering, science, or technical field with 5+ years of relevant experience.
- Must have working knowledge of medical device compliance standards (ISO 13485, IEC 62304, HIPAA, FDA QMSR) and data privacy regulations.
Responsibilities
- Lead as a quality core team member for digital health solutions (mobile, web, cloud).
- Oversee software lifecycle activities across Agile/Waterfall/DevOps with traceability.
- Lead risk management activities including software FMEAs and defect triage.
- Develop and maintain software quality standards and CAPA initiatives.
- Support regulatory audits and quality management system reviews.
- Assist post-market activities as needed.
Skills
Education
Tools
Job description
MiniMed is seeking a Principal Software Quality Engineer to lead quality efforts for digital health products including mobile apps, web apps, and cloud solutions. Hybrid role based in Northridge, CA, combining R&D collaboration with quality governance across Agile/Waterfall/DevOps processes.
You will drive design reviews, risk analysis, CAPA projects, and regulatory alignment with ISO 13485, IEC 62304, HIPAA, and FDA QMSR requirements, while supporting internal and external audits and
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