We anticipate the application window for this opening will close on - 16 Oct 2026

About the Role

The Senior Software Quality Engineer works as part of the core new product development team to drive software quality activities for digital health solutions, including mobile applications (iOS/Android), web applications, and cloud-based data-driven solutions. The candidate must possess a solid understanding of 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

Quality Core Team

• Engage 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; drive the collaborative quality strategy for projects in alignment with business goals for cross-functional teams including R&D, Regulatory, Marketing, and Operations.

Software Evaluation and Compliance

• Drives quality oversight and evaluation of software systems activities within the software development lifecycle (Agile/Waterfall/DevOps) across requirements, design, development, documentation, integration, test, verification and validation; participates in design reviews and reviews and approves design input/design output artifacts including requirements, design documents, test results, verification and validation reports, and defects; ensures project and process control documentation comply with procedural requirements, applicable standards and regulations, with full requirement traceability maintained.

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, requirements and objectives.

CAPA & Quality Improvement

• Lead and drive CAPA (Corrective and Preventative Action) projects; drive 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; participates in 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 4+ years of relevant experience in Quality, Engineering, and/or Software Development OR
• Advanced Degree in Engineering, Science, or Technical Field with 2+ years of relevant experience in Quality, Engineering, and/or Software Development.
• Must have working knowledge of medical device compliance standards including IEC 62304, 13485, 14971, and FDA QMSR.
• 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.

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 is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package

At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.
Salary ranges for U.S (excl. PR) locations (USD):$87,000.00 - $149,000.00
For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $97,000 - $165,000 USD.

Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

This position is eligible for a short-term incentive called the Short Term Incentive (STI).

At MiniMed, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements. Please note that "regular employees" refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico.

For further details about our comprehensive benefits, we encourage you to visit the link below.

MiniMed Benefits Overview