Senior Embedded Firmware Quality Engineer

MiniMed Group; California, Northern (MO, KY); Hybrid; USD 97,000 - 165,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with company match

Paid time off

Job summary

MiniMed is seeking a Senior Software Quality Engineer to join the core product team in a hybrid Northridge, CA-based role. You will drive quality activities for embedded firmware, manage risk analyses, and ensure compliance with design controls and QMS requirements.

The role partners with Regulatory, R&D, Marketing, Medical Safety, and post-market Quality to implement continuous improvement and robust verification, validation and documentation.

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 with 2+ years of experience.
• Nice to have knowledge of IEC 62304, 13485, 14971 and FDA QMSR.

Responsibilities

• Participate in software FMEA and hazard analyses.
• Drive design controls, risk management, and change control with cross-functional teams.
• Review requirements, design artifacts, code reviews, and verification/validation reports.
• Support Quality Management System reviews and CAPAs as needed.

Skills

Embedded firmware

Quality engineering

FMEA

Regulatory compliance

Communication skills

Education

Bachelor’s degree in Engineering/Science/Technical field

Advanced degree (MS/PhD) in related field

Job description

MiniMed is seeking a Senior Software Quality Engineer to join the core product team in a hybrid Northridge, CA-based role. You will drive quality activities for embedded firmware, manage risk analyses, and ensure compliance with design controls and QMS requirements.

The role partners with Regulatory, R&D, Marketing, Medical Safety, and post-market Quality to implement continuous improvement and robust verification, validation and documentation.