Principal Software Quality Engineer

We anticipate the application window for this opening will close on - 16 Oct 2026. At Mini Med, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

The Principal Software Quality Engineer works as part of the core new product development team to lead software quality activities for digital health solutions, including mobile applications (iOS/Android), web applications, and cloud-based data-driven solutions. The candidate must possess deep expertise in software development life cycle processes (Waterfall/Agile/Dev Ops) as applied within the regulated medical device industry. This is a Hybrid role based in Northridge, CA.

May Include the Following and Other Duties May Be Assigned:

• Core Team Member Lead as a quality core team member responsible for driving quality into the design and development of digital health solutions including medical 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 Dev Ops.
• Software Evaluation and Compliance:
  Leads quality oversight and evaluation of software systems activities across the software development lifecycle (Agile/Waterfall/Dev Ops) including requirements, design, development, documentation, integration, test, verification and validation; leads design reviews and reviews and approves design input/design output artifacts ensuring project and process control documentation comply with procedural requirements, applicable standards and regulations, with full requirement traceability maintained and documented.
• Risk Management & Defect Management:
  Lead and conduct risk management activities including system risk analysis and software FMEAs; manages and triages software issues with the cross‑functional teams.
• Quality Standards & Program Development:
  Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures; develops overall operating criteria to ensure implementation of the software quality program according to project, process, and contract requirements and objectives.
• CAPA & Quality Improvement:
  Lead and drive CAPA (Corrective and Preventative Action) projects; lead quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures.
• Audits & Regulatory Compliance:
  Participate in both internal and external regulatory audits and inspections; and supports Quality Management System reviews of Standard Operating Procedures aligned with US and international standards.
• Post‑Market Support:
  Supports post‑market team for FCAs or HRAs as needed.

• Must Have:
  
  Minimum Requirements:
  
  Bachelor's degree in engineering, Science, or Technical Field with 7+ years of relevant experience in Quality, Engineering, and/or Software Development OR Advanced Degree in Engineering, Science, or Technical Field with 5+ years of relevant experience in Quality, Engineering, and/or Software Development.
• Must have 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.
• Nice to Have:
  Experience in software design and development, verification, validation, and testing activities for mobile…