Senior Embedded Firmware Quality Engineer

MiniMed; Los Angeles (CA); On-site; USD 97,000 - 165,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) with company match

Employee Stock Purchase Plan

Job summary

MiniMed is seeking a Senior Software Quality Engineer to drive embedded firmware quality within the core product team. You will lead risk management activities, contribute to design controls, and collaborate with Regulatory, R&D, Marketing, and Quality teams to ensure high-quality product development and post-market support.

The role requires strong communication skills, experience with software quality processes in a regulated medical device environment, and the ability to support audits and

Qualifications

• Bachelor’s degree in Engineering, Science or Technical field with 4+ years of relevant experience in Quality, Engineering and/or Software Development.
• 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 FMEA and hazard analysis.
• Drive quality with R&D through design controls, risk management and change control processes.
• Participate in design reviews and review artifacts such as requirements, design documents and test reports.
• Manage and triage software issues with R&D.
• Support Quality Management System reviews of SOPs aligned with US and international standards.
• Ensure requirement traceability is documented and maintained.
• Communicate effectively across multiple hierarchical levels.
• Support CAPAs and post-market activities as needed.
• Assist internal and external audits.

Skills

FMEA

Design controls

Risk management

Verification & validation

Cross-functional collaboration

Communication (verbal & written)

Software quality

Education

Bachelor’s degree in Engineering, Science or Technical field

Advanced degree in Engineering, Science or Technical field

Tools

IEC 62304

IEC 13485

FDA QMSR

Regulatory standards

Job description

MiniMed is seeking a Senior Software Quality Engineer to drive embedded firmware quality within the core product team. You will lead risk management activities, contribute to design controls, and collaborate with Regulatory, R&D, Marketing, and Quality teams to ensure high-quality product development and post-market support.

The role requires strong communication skills, experience with software quality processes in a regulated medical device environment, and the ability to support audits and