Senior Software Quality Engineer - Embedded Medical Devices
MiniMed
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Benefits offered by this job
Job summary
MiniMed is seeking a Senior Software Quality Engineer in California to lead the software quality efforts for embedded firmware. You will drive risk management activities, participate in design reviews, and collaborate across Regulatory, R&D, Marketing, and Quality to ensure compliant product development.
The role emphasizes strong communication, cross-functional teamwork, and ongoing improvements to the Quality Management System, with a focus on FMEA, design controls, and post-market support
Qualifications
- Bachelor's degree with 4+ years in Quality/Engineering/Software Development or advanced degree with 2+ years in Quality/Engineering/Software Development.
- Familiarity with medical device quality systems and IEC 62304/13485/14971 is a plus.
- Strong verbal and written communication in a cross-functional environment.
Responsibilities
- Participate in product risk management activities including FMEA and hazard analysis.
- Drive quality compliance with R&D, design controls, risk management and change control processes.
- Review design inputs/outputs, requirements, design docs, code reviews, and verification/validation reports.
- Manage and triage software issues with R&D team.
- Support Quality Management System reviews of SOPs aligning with US and international standards.
- Ensure traceability is maintained and documented.
- Support CAPAs and post-market activities as needed (FCA/HRA).
- Support internal and external audits.
Skills
Education
Job description
MiniMed is seeking a Senior Software Quality Engineer in California to lead the software quality efforts for embedded firmware. You will drive risk management activities, participate in design reviews, and collaborate across Regulatory, R&D, Marketing, and Quality to ensure compliant product development.
The role emphasizes strong communication, cross-functional teamwork, and ongoing improvements to the Quality Management System, with a focus on FMEA, design controls, and post-market support
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