Hybrid Medical Software Quality Engineer

USA-Medtronic MiniMed, Inc 1017; Los Angeles (CA); Hybrid; USD 109,000 - 185,000; Full time

Job summary

MiniMed in Northridge, CA is seeking a Principal Software Quality Engineer to lead software quality activities for digital health solutions, including mobile apps, web, and cloud-based data platforms. You will apply SDLC processes (Waterfall/Agile/DevOps) within a regulated medical device environment.

You will drive risk management, CAPA, audits, regulatory compliance, and quality program development while mentoring cross‑functional teams across R&D, Regulatory, and DevOps.

Qualifications

• Bachelor's degree in engineering, science, or technical field with 7+ years of relevant experience.
• Advanced degree with 5+ years of relevant experience.
• Working knowledge of ISO 13485, IEC 62304, HIPAA, FDA QMSR, security standards, and data privacy regulations.
• Experience with SDLC in Agile/Waterfall/DevOps within regulated medical devices.
• Experience using ALM tools (PTC Integrity, Atlassian Suite, TFS) and Jira.
• Exposure to wireless protocols such as Bluetooth.
• CQE or CSQE certification preferred.

Responsibilities

• Lead quality activities for digital health solutions including mobile apps, web, and cloud platforms.
• Oversee software lifecycle activities with full requirement traceability and design input/output reviews.
• Lead risk management, FMEAs, defect triage, and CAPA initiatives.
• Develop and maintain software quality standards and operating procedures.
• Participate in regulatory audits and post‑market support as needed.

Skills

Quality engineering

SDLC

Regulatory compliance

Risk management

Education

Bachelor's degree in engineering/science/technical field

Advanced degree in engineering/science/technical field

Tools

ALM tools (PTC Integrity, Atlassian Suite, TFS)

Jira

Job description

MiniMed in Northridge, CA is seeking a Principal Software Quality Engineer to lead software quality activities for digital health solutions, including mobile apps, web, and cloud-based data platforms. You will apply SDLC processes (Waterfall/Agile/DevOps) within a regulated medical device environment.

You will drive risk management, CAPA, audits, regulatory compliance, and quality program development while mentoring cross‑functional teams across R&D, Regulatory, and DevOps.