Sr Quality Engineer (New Product Development)
About The Position
MiniMed is seeking a detail-oriented Senior Quality Engineer to lead 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 provides design quality leadership throughout product development, from concept through commercialization, and ensures products meet FDA regulations, ISO 13485, applicable global regulatory standards, and company procedures. The position requires working on-site in Northridge, California, at least three days per week. The role partners across engineering and product teams to guide design controls, requirements traceability, verification and validation, risk management, defect resolution, and design transfer. It also supports audits and regulatory inspections. The position includes a short-term incentive and a competitive salary and flexible benefits package.
Requirements
- At least 4 years of experience in a Design Quality role within a regulated medical device environment, or an advanced degree and at least 2 years of such experience.
- Bachelor’s degree in engineering, science, or a related discipline.
- 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 product 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 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 risk management for assigned products, 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 according to ISO 14971 and applicable standards.
- Identify and document CTQ parameters based on risk assessment results and ensure effective controls are implemented.
- Lead investigation and resolution of defects found during design verification and in field reports, using risk-based decision-making and the defect tracking process.
- Review, support, and approve design transfer activities to ensure 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.
- Short-term incentive (STI).
- Health insurance.
- Dental insurance.
- Vision insurance.
- Health Savings Account access.
- Healthcare Flexible Spending Account access.
- Life insurance.
- Long-term disability leave.
- Dependent daycare spending account.
- Incentive plans.
- 401(k) plan with company match.
- Short-term disability coverage.
- Paid time off and holidays.
- Employee Stock Purchase Plan participation.
- Employee Assistance Program access.
- Eligible employees may have access to a Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
