Principal Quality Engineer

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

About the Role

In this critical role, you will serve as a cornerstone of our day-to-day manufacturing quality operations ensuring our products meet the highest standards of accuracy, reliability, and regulatory compliance.

You will play an integral part in the launch of next-generation medical device products, leading test method validations, driving risk mitigation strategies, and collaborating with cross-functional teams to bring life-changing technology to patients who depend on it. This is an opportunity to directly influence product integrity and patient outcomes in a fast-paced, highly regulated medical device environment. If you are a detail-oriented, proactive, and collaborative quality professional who thrives on solving complex challenges and delivering results, this role is for you.

Ready to make an impact? Apply now and join our team!

Responsibilities may include the following and other duties may be assigned.

On Site Role

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.

• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

• Devises and 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.

• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

• Leads quality engineering activities in support of new product introduction (NPI), including design transfer, process validation, and launch readiness assessments, to ensure a smooth transition from development to full-scale manufacturing in compliance with regulatory and quality requirements.

• Proactively identifies, evaluates, and mitigates quality risks across the manufacturing process utilizing risk management tools such as FMEA, Control Plans, and ISO 14971 frameworks to prevent quality escapes and minimize impact to production schedules and customer deliverables.

• Develops, executes, and maintains test method validations (TMV) including method development, qualification, and revalidation activities to ensure measurement systems are accurate, reliable, and compliant with applicable regulatory standards and internal quality requirements.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor’s degree with 7+ years’ relevant experience, or Advanced degree with 5+ years of experience.

Nice To Have:

• Proficiency in statistical analysis tools such as Minitab or equivalent, with hands-on experience applying statistical process control (SPC), Design of Experiments (DOE), and data-driven problem-solving methodologies to drive quality improvements in a high-volume manufacturing setting.

• Proven experience in Corrective and Preventive Action (CAPA) ownership, including the ability to lead end-to-end CAPA investigations, perform thorough root cause analyses using methodologies such as 8D, Fishbone, and 5-Why, and drive timely, sustainable corrective actions to closure in compliance with regulatory requirements.

Physical Job Requirements

The 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.

For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $121,000 - $205,000 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).

At MiniMed, we are committed to supporting the well-being and financial security of our employees. 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 Overview

About MiniMed

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. 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.

If you are applying to perform work for MiniMed in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. 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.