Lead Software Quality Engineer – Medical Devices (Hybrid)

MiniMed; Los Angeles (CA); Hybrid; USD 109,000 - 185,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) match

Stock purchase plan

Paid time off

Job summary

MiniMed is seeking a Principal Software Quality Engineer to lead quality activities across digital health solutions, including mobile apps, web apps, and cloud data services. The role requires deep SDLC expertise within regulated medical devices and a strong ability to drive design reviews, risk management, and CAPA programs.

The position is hybrid in Northridge, CA, with responsibilities spanning cross-functional teams in R&D, Regulatory, Marketing, and DevOps to ensure compliant, high-quality

Qualifications

• Bachelor’s degree in engineering, science, or technical field with 7+ years of relevant experience.
• Advanced degree with 5+ years of relevant experience in Quality, Engineering, and/or Software Development.
• Working knowledge of ISO 13485, IEC 62304, HIPAA, FDA QMSR, security standards, and data privacy regulations.
• Ability to author technical reports, business correspondence, and standard operating procedures.

Responsibilities

• Lead as a quality core team member for digital health solutions including mobile, web, cloud, data reports and AI/ML; align quality strategy with cross-functional teams.
• Oversee software lifecycle activities (requirements, design, development, documentation, integration, test, V&V) and ensure traceability.
• Lead risk management activities including system risk analysis and software FMEAs; triage software issues with cross-functional teams.
• Develop and maintain software quality standards and operating procedures per project and contract requirements.
• Lead CAPA projects and quality improvement initiatives to meet compliance standards.
• Participate in internal and external regulatory audits and Quality Management System reviews.

Skills

SDLC expertise

Team leadership

Regulatory compliance

Medical device industry

Technical writing

Quality assurance

Education

Bachelor's degree in engineering/science

Advanced degree in engineering/science

Tools

Jira

Atlassian Suite

PTC Integrity

TFS

Job description

MiniMed is seeking a Principal Software Quality Engineer to lead quality activities across digital health solutions, including mobile apps, web apps, and cloud data services. The role requires deep SDLC expertise within regulated medical devices and a strong ability to drive design reviews, risk management, and CAPA programs.

The position is hybrid in Northridge, CA, with responsibilities spanning cross-functional teams in R&D, Regulatory, Marketing, and DevOps to ensure compliant, high-quality