Senior Quality Engineer
MiniMed
Summary
As a Senior Quality Engineer on our team, you will serve as a critical quality authority across our manufacturing operations — developing and maintaining quality standards, driving process validation, and ensuring every product that leaves our facility meets the highest standards of precision, compliance, and patient safety.
Job description
Responsibilities
- Develops, modifies, applies and maintains quality standards and protocols for processing materials into partially finished or finished products, ensuring compliance with FDA, ISO 13485, and 21 CFR Part 820 requirements
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place and continuously improved across the production lifecycle
- Plans, implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
- Support end-to-end process validation (IQ/OQ/PQ) activities including protocol development, execution, and formal reporting in alignment with regulatory requirements
- Develops and validates test methods (TMV) including gauge R&R, measurement system analysis (MSA), accuracy, precision, and linearity studies to ensure reliable and reproducible results
- Applies statistical tools such as SPC, DOE, and capability studies to identify trends, reduce variation, and drive continuous quality improvements
- Authors and reviews validation protocols, technical reports, and quality documentation to support manufacturing and new product launches
- Supports CAPA, non-conformance, and deviation management processes by performing thorough root cause analysis and implementing effective corrective actions
- Serves as a quality resource on the manufacturing floor, providing guidance on process deviations and non-conformances in real time
- Partners with cross-functional teams to implement new manufacturing lines by establishing robust process controls, defining critical quality attributes, and ensuring lines are validated and production-ready prior to full-scale launch
Minimum Requirements
Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality
Nice to Have
- Experience with root cause analysis methods (Fishbone, 5 Whys, Is or Is Not?)
- Ability to communicate technical knowledge to other engineers as part of a large collaborative work environment
- Ability to manage multiple projects and activities
- Strong communication skills
- Willingness to learn and adapt to new challenges on a broad spectrum of topics
Requirements
- Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality
- Experience with root cause analysis methods (Fishbone, 5 Whys, Is or Is Not?)
- Ability to communicate technical knowledge to other engineers as part of a large collaborative work environment
- Ability to manage multiple projects and activities
- Strong communication skills
- Willingness to learn and adapt to new challenges on a broad spectrum of topics
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Health savings account
- Healthcare flexible spending account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- 401(k) plan with company match
- Short-term disability coverage
- Paid time off
- Holidays
- Employee stock purchase plan
- Employee assistance program
- Non-qualified retirement plan supplement
- Capital accumulation plan
Company overview
MiniMed is a leading medical device company specializing in diabetes management technologies, with a rich history dating back to its founding in 1983 by visionary entrepreneur Alfred E. Mann. Originally acquired by Medtronic in 2001, MiniMed recently became an independent publicly-traded company in 2026, trading on Nasdaq under the ticker "MMED" with a market capitalization of approximately $5.29 billion. The company is headquartered in Northridge, California, and employs nearly 8,000 dedicated professionals focused on advancing diabetes care. MiniMed is unique as the only diabetes technology company that manufactures both insulin pumps and continuous glucose monitors (CGMs), offering integrated systems like the MiniMed 780G system with SmartGuard technology. Their flagship products include automated insulin delivery systems, continuous glucose monitoring sensors, and smart insulin pens designed to simplify diabetes management and improve patient outcomes. With a mission to make diabetes more predictable and manageable, MiniMed has established itself as a pioneer in diabetes technology, providing innovative solutions that help patients achieve better glucose control and enhance their quality of life.