Principal Software Quality Engineer

USA-MiniMed Distribution Corp. 1018; Los Angeles (CA); Hybrid; USD 140,000 - 180,000; Full time

Job summary

MiniMed is seeking a Principal Software Quality Engineer to lead quality efforts for digital health products including mobile apps, web apps, and cloud solutions. Hybrid role based in Northridge, CA, combining R&D collaboration with quality governance across Agile/Waterfall/DevOps processes.

You will drive design reviews, risk analysis, CAPA projects, and regulatory alignment with ISO 13485, IEC 62304, HIPAA, and FDA QMSR requirements, while supporting internal and external audits and

Qualifications

• Bachelor's degree in engineering, science, or technical field with 7+ years of relevant experience.
• Advanced Degree in engineering, science, or technical field with 5+ years of relevant experience.
• Must have working knowledge of medical device compliance standards (ISO 13485, IEC 62304, HIPAA, FDA QMSR) and data privacy regulations.

Responsibilities

• Lead as a quality core team member for digital health solutions (mobile, web, cloud).
• Oversee software lifecycle activities across Agile/Waterfall/DevOps with traceability.
• Lead risk management activities including software FMEAs and defect triage.
• Develop and maintain software quality standards and CAPA initiatives.
• Support regulatory audits and quality management system reviews.
• Assist post-market activities as needed.

Skills

Quality engineering

Software SDLC

Regulatory compliance

Risk management

Education

Bachelor's degree in engineering, science, or technical field

Advanced degree in engineering, science, or technical field

Tools

PTC Integrity

Atlassian Suite

TFS

Jira

Job description

We anticipate the application window for this opening will close on - 6 Nov 2026

At MiniMed, 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.

About the Role

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/DevOps) as applied within the regulated medical device industry. This is a Hybrid role based in Northridge, CA

Responsibilities 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 DevOps.


• Software Evaluation and Compliance Leads quality oversight and evaluation of software systems activities across the software development lifecycle (Agile/Waterfall/DevOps) 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.

Qualifications

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 application development (and/or web applications and cloud infrastructure services (Amazon AWS/Microsoft Azure).


• Experience executing in the SDLC environment leveraging ALM tools (e.g., PTC Integrity/Atlassian Suite/TFS), defect tracking tools (e.g., Jira/PTC)


• Exposure to wireless communication protocols (e.g., Bluetooth).


• Working knowledge of integrated digital health systems including consumer products such as Apple/Android products.


• CQE or CSQE Certification preferred.

#BetterDaysStartNow

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee