Senior Quality Engineer

About the Role: At MiniMed, every product we build has one purpose — to help people living with diabetes live healthier, safer, and more fulfilling lives. As a Senior Quality Engineer on our team, you will be at the heart of making that possible. In this high-impact role, 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. From designing inspection mechanisms and executing test method validations to leading root cause analysis and supporting new manufacturing line launches, your expertise will touch every stage of the production lifecycle. You will collaborate closely with Engineering, Manufacturing, and cross-functional teams to build robust process controls, reduce variation, and champion a culture of continuous improvement — all within a highly regulated environment governed by FDA, ISO 13485, and 21 CFR Part 820 requirements. This is not just a quality role — it is an opportunity to directly influence the safety and reliability of life‑changing medical technology. If you are a detail‑driven, analytically minded quality professional who thrives at the intersection of science, compliance, and collaboration — we want to hear from you.

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 Supports 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

Must Have: Minimum RequirementsBachelor’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 Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co‑workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation: MiniMed offers a competitive salary and flexible benefits package At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Salary ranges for U.S (excl. PR) locations (USD):$87,000.00 - $149,000.00 For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $97,000 - $165,000 USD. Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). This position is eligible for a short‑term incentive called the Short Term Incentive (STI). Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long‑term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short‑term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non‑qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements. Please note that “regular employees” refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico. For further details about our comprehensive benefits, we encourage you to visit the link below. MiniMed Benefits OverviewMiniMed is a full‑stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey — when and how they need it. For more than 40 years, we’ve been committed to redefining what’s possible: intelligent dosing systems designed for real life, predictive insights that stay a step ahead, and always on support when it’s needed most. At the heart of everything we do is a simple Mission: to make every day a better day for people with diabetes. Learn more about our business, and our mission here. It is the policy of MiniMed to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, familial status, membership or activity in a local human rights commission, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities. In addition, the policy of MiniMed to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, familial status, membership or activity in a local human rights commission, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities. MiniMed will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. MiniMed is a full‑stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey — when and how they need it. From our intelligent dosing systems that stay one step ahead to our always‑on support when it’s needed most, we’re committed to building a connected system of care that works together and fits into everyday life, so people with diabetes can move through the day with fewer interruptions. Fewer second guesses. And more freedom to live in the moment. We’re here to make better days possible for people with diabetes. Joyful, messy, fully lived days. Days where things feel lighter, easier. For more than four decades, we’ve been driven by this mission, delivering groundbreaking advancements in technology to help people live more fully, freely, and with greater confidence. At MiniMed, diabetes care is personal for us. Many of our employees have a connection to diabetes, whether they're living with it themselves or through family members and friends, and we all show up each day to help make the lives of our coworkers and loved ones easier. Our people‑first priority. At MiniMed, we put our customers at the forefront of all we do, and that focus extends to our team as well. We're dedicated to creating a culture of belonging and providing our people with all the career‑building resources you might need. Our life‑transforming technologies. No matter what your role at our company, you're making a difference in the lives of people with diabetes. Our innovative inventions improve their day‑to‑day by helping lift the mental load and allowing diabetes to fade into the background, empowering them to live life on their own terms. Our focus on the future. We're chasing the dream of a world where people with diabetes can be free of that never‑ending battle of balancing blood sugar. A world where better days are the norm, not the exception. Fresh faces and new viewpoints will help create our cutting‑edge solutions and define the next generation of breakthroughs in care, so that a better day can start today. It is the policy of MiniMed to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E‑Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status.