Sr Quality Engineer (New Product Development)

MiniMed • Los Angeles, CA

7d • $87,000 - $149,000 • Hybrid

About The Position

MiniMed is seeking a highly motivated, detail-oriented Senior Quality Engineer to lead and implement Design Quality Engineering activities for diabetes management products, including insulin pumps, continuous glucose monitoring systems, and closed-loop or automated insulin delivery systems. The role ensures designs comply with FDA regulations, ISO 13485, applicable global regulatory standards, and internal procedures, and provides design quality leadership throughout product development, from concept through commercialization. The position requires on-site work in Northridge, California, at least three days per week.

Requirements

• Bachelor’s degree in engineering, science, or a related discipline.
• At least 4 years of experience in a Design Quality role within a regulated medical device environment, or an advanced degree with at least 2 years of experience.
• At least 2 years of experience leading risk management activities across the product lifecycle.

Nice To Haves

• ASQ Certified Quality Engineer (CQE).
• Experience with Software as a Medical Device (SaMD) or electromechanical systems, specifically IEC 62304.
• Prior experience in the diabetes or infusion pump industry.
• Proficiency in statistical software such as Minitab for trend analysis and data-driven assessments.
• Six Sigma Green Belt or Black Belt certification.
• Strong working knowledge of FDA QSR, ISO 13485, ISO 14971, and statistical techniques.
• Strong verbal and written communication skills, including the ability to facilitate cross-functional risk and defect discussions.
• Strong organizational skills, including the ability to multitask, prioritize, follow up, meet deadlines, and attend to detail.

Responsibilities

• Lead system-level Design Assurance and Design Control activities for new development and sustaining design changes, ensuring compliance with FDA QSR, ISO 13485, MDSAP, and global regulatory requirements.
• Ensure system, subsystem, and software requirements are clearly defined, risk-based, traceable, and verified across hardware, firmware, mobile apps, and cloud components.
• Review and approve system-level design outputs for safety, usability, cybersecurity, interoperability, and performance requirements.
• Support development, review, and execution of system-level Verification and Validation (V&V) plans, protocols, and reports.
• Ensure test coverage across hardware, embedded software, mobile applications, algorithms, and cloud components.
• Review and approve test method validation, test procedures, statistical analysis approaches, and acceptance criteria.
• Lead product risk management, including development and implementation of risk management plans, reports, FMEAs, and integrated system risk assessments.
• Ensure hardware, software, mobile app, usability, cybersecurity, connectivity, and interoperability risks are identified, mitigated, and verified in accordance with ISO 14971 and applicable standards such as IEC 60601 and IEC 62366.
• Identify and document critical-to-quality (CTQ) parameters based on risk assessment results and ensure effective controls are implemented.
• Lead investigation and resolution of defects identified during design verification and through field reports, using risk-based decision-making and the defect tracking process.
• Review, support, and approve design transfer activities to ensure design requirements are effectively transferred to manufacturing, including IQ, OQ, PQ, process validation, and inspection plans.
• Lead root cause analysis and CAPA activities using structured problem-solving methodologies.
• Assist with internal audits, Notified Body audits, and regulatory inspections.

Benefits

• Competitive salary and 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 a short-term incentive (STI).
• 401(k) plan with company match.
• Short-term disability coverage.
• Paid time off and holidays.
• Employee Stock Purchase Plan.
• Employee Assistance Program.
• Eligible employees may have access to 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