Hybrid Senior Software Quality Engineer — Digital Health

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

Job summary

MiniMed seeks a Principal Software Quality Engineer to drive quality across digital health solutions, including mobile apps, web and cloud platforms. You will lead quality activities across SDLC, ensuring compliance with ISO 13485, IEC 62304, HIPAA, and FDA QMSR, and manage risk, CAPA, and audits within a hybrid Northridge, CA setting.

The role requires deep SDLC expertise in Waterfall/Agile/DevOps within regulated medical devices, cross-functional collaboration, and strong technical writing.

Qualifications

• Must have 7+ years of relevant experience in Quality, Engineering, and/or Software Development.
• Advanced Degree in Engineering, Science, or Technical Field with 5+ years of experience in Quality, Engineering, and/or Software Development.
• Working knowledge of medical device compliance standards including 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 responsible for driving quality into the design and development of digital health solutions including mobile device applications (iOS/Android), web applications, cloud technologies (AWS/IBM Watson), data reports, and AI/ML solutions; lead the collaborative quality strategy for projects in alignment with business goals for cross-functional teams including R&D, Med Safety, Regulatory, Marketing, and DevOps.

Skills

Quality engineering

Regulatory compliance

Technical writing

Education

Bachelor’s degree in engineering/science/technical field

Advanced degree in engineering/science/technical field

Tools

PTC Integrity

Atlassian Suite

Jira

TFS

Job description

MiniMed seeks a Principal Software Quality Engineer to drive quality across digital health solutions, including mobile apps, web and cloud platforms. You will lead quality activities across SDLC, ensuring compliance with ISO 13485, IEC 62304, HIPAA, and FDA QMSR, and manage risk, CAPA, and audits within a hybrid Northridge, CA setting.

The role requires deep SDLC expertise in Waterfall/Agile/DevOps within regulated medical devices, cross-functional collaboration, and strong technical writing.