Senior Embedded QA Engineer – Medical Devices (Hybrid)

MiniMed

San Diego (CA)

Hybrid

USD 97,000 - 165,000

Full time

3 days ago
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Benefits offered by this job

Health, dental, and vision insurance
401(k) with company match
Short-term incentive (STI)

Job summary

MiniMed is seeking a Senior Software Quality Engineer in Northridge, CA to drive embedded firmware quality, participate in risk assessments, and lead QMS deliverables within our core product team. You will collaborate with Regulatory, R&D, Marketing, Medical Safety, and post-market Quality to implement continuous improvement strategies.

The role requires a strong background in design controls, risk management, and software lifecycle processes within a regulated medical device environment.

Qualifications

  • Bachelor’s degree in Engineering, Science or Technical field with 4+ years of relevant experience in Quality, Engineering and/or Software Development OR Advanced Degree in Engineering, Science or Technical field with 2+ years of relevant experience in Quality, Engineering and/or Software Development.

Responsibilities

  • Participate in product risk management activities including software FMEA and hazard analyses.
  • Drive quality compliance with R&D, including design controls, risk management, and change control processes.
  • Review design input/output artifacts, requirements, design docs, code reviews, and verification/validation reports.
  • Manage and triage software issues with R&D.
  • Support Quality Management System reviews of SOPs aligning with US and international standards.
  • Ensure requirement traceability is met and documented.

Skills

Embedded firmware
FMEA
Risk management
Design controls
Communication

Education

Bachelor’s degree in Engineering/Science/Technical field
Advanced degree in Engineering/Science/Technical field

Job description

MiniMed is seeking a Senior Software Quality Engineer in Northridge, CA to drive embedded firmware quality, participate in risk assessments, and lead QMS deliverables within our core product team. You will collaborate with Regulatory, R&D, Marketing, Medical Safety, and post-market Quality to implement continuous improvement strategies.

The role requires a strong background in design controls, risk management, and software lifecycle processes within a regulated medical device environment.

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