Sr Quality Engineer (New Product Development)

MiniMed • Los Angeles, CA

4d • $87,000 - $149,000 • Hybrid

About The Position

The Senior Quality Engineer will lead and implement Design Quality Engineering activities for diabetes management products, including insulin pumps, continuous glucose monitoring (CGM) systems, and closed-loop or automated insulin delivery systems. The role ensures product designs comply with FDA regulations, ISO 13485, applicable global regulatory standards, and internal company procedures. As a quality partner throughout product development, the engineer provides design quality leadership from concept through commercialization. The role requires working on-site 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 maintain attention 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 to ensure safety, usability, cybersecurity, interoperability, and performance requirements are met.
• Support development, review, and execution of system-level Verification and Validation (V&V) plans, protocols, and reports.
• Ensure comprehensive 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 activities, including development and implementation of risk management plans, reports, FMEAs, and integrated system risk assessments.
• Ensure risks related to hardware, software, mobile apps, usability, cybersecurity, connectivity, and interoperability are identified, mitigated, and verified per ISO 14971 requirements 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 from 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 eligibility for 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