Senior Software Quality Engineer

MiniMed • San Diego, CA

3d • $97,000 - $165,000 • Hybrid

About The Position

The Senior Design Quality Engineer serves as a quality partner within the core product development team, driving design quality, risk management, and compliance throughout the product lifecycle. The role is distinct from software development and software testing and focuses on design controls, risk management, and quality systems. The position collaborates with R&D software development and test, Regulatory, Marketing, Medical Safety, and Post-Market Quality to integrate quality principles and risk management into product development and support continuous improvement. It is a hybrid role based in Northridge, California.

Requirements

• Bachelor's degree in Engineering, Science, or a technical field and at least 4 years of relevant experience in Quality, Engineering, and/or Software Development; or an advanced degree in one of these fields and at least 2 years of relevant experience.
• Working knowledge of medical device compliance standards, including IEC 62304, ISO 13485, ISO 14971, and FDA QMSR.
• Ability to author technical reports, business correspondence, and standard operating procedures.

Nice To Haves

• Experience with software design and development, verification, validation, and testing for mobile applications and/or web applications and cloud infrastructure services such as Amazon AWS or Microsoft Azure.
• Experience executing work in an SDLC environment using ALM tools such as PTC Integrity, Atlassian Suite, or TFS, and defect tracking tools such as Jira or PTC.
• Exposure to wireless communication protocols such as Bluetooth.
• Working knowledge of integrated digital health systems, including consumer products such as Apple or Android products.
• CQE or CSQE certification.

Responsibilities

• Serve as a quality core team member for digital health product development, including medical mobile applications, web applications, cloud technologies, data reports, and AI/ML solutions; develop collaborative quality strategies aligned with business goals.
• Provide quality oversight across software development lifecycle activities, including requirements, design, development, documentation, integration, testing, verification, and validation.
• Participate in design reviews and review and approve design input and output artifacts, including requirements, design documents, test results, verification and validation reports, and defects.
• Ensure project and process control documentation complies with procedures, applicable standards, and regulations, with full requirements traceability maintained.
• Lead system risk analyses and software FMEAs, and manage and triage software issues with cross-functional teams.
• Develop, modify, apply, and maintain standards, methods, processes, procedures, and operating criteria for software systems quality programs.
• Lead and drive Corrective and Preventive Action (CAPA) projects and quality improvement projects.
• Participate in internal and external regulatory audits and inspections, and support Quality Management System reviews of Standard Operating Procedures aligned with U.S. and international standards.
• Support the post-market team with FCAs or HRAs as needed.

Benefits

• Flexible benefits package.
• Health insurance.
• Dental insurance.
• Vision insurance.
• Health Savings Account.
• Healthcare Flexible Spending Account.
• Life insurance.
• Long-term disability leave.
• Dependent daycare spending account.
• Incentive plans, including eligibility for the Short Term Incentive.
• 401(k) plan with company match.
• Short-term disability coverage.
• Paid time off and holidays.
• Employee Stock Purchase Plan.
• Employee Assistance Program.
• Potential eligibility for a Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior