Principal Quality Engineer - Process Development

Location: Los Angeles, California, United States of America · On-Site

We anticipate the application window for this opening will close on - 9 Nov 2026

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

This Principal Design Quality Engineer will oversee quality records and strategy for low to mid-volume manufacturing lines and new product scale-up across various product platforms. Success in this role requires a high degree of professional discretion to ensure teams operate in accordance with standard operating procedures while maintaining a pragmatic, collaborative approach. Sitting squarely at the intersection of multiple cross-functional groups, you must act as a trusted partner and influencer who clears roadblocks and builds alignment.

Key Responsibilities

Process Development & Validation

• Develop P-diagrams, Input-Process-Output matrices, process characterizations, and test method validation strategies for NPI programs.
• Author and manage Master Validation documents (IQ/OQ/PQ/EQV/TMV) for new product introductions and production scale-up.
• Apply methodologies including Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA), and Cell Operating System (COS).
• Drive risk mitigation approaches by integrating qualification parts early in process development phases

Process Risk Management & Risk Navigation

• Facilitate and generate Process Failure Modes Effects Analysis (pFMEA) documents for manufacturing processes during NPI and scale-up.
• Maintain strong working knowledge of design risk documentation (RAD, dFMEA) to critically analyze process-related failures and identify gaps.
• Recognize when process findings have design risk implications and escalate appropriately to Design Quality Assurance partners for design risk assessment decisions.
• Leverage understanding of risk documentation during root cause investigations and critical analyses to ensure comprehensive disposition.
• Conduct thorough root cause investigations using A3 Problem Solving methodology, fishbone diagrams, 5-Why analysis, and brainstorming techniques

Cross-Functional Engagement & Collaboration

• Facilitate regular cadence of alignment discussions with Supplier Quality and vendors to implement updated control plans, inspection criteria, and risk documentation.
• Collaborate with R&D teams to translate design intent into manufacturable process parameters during design transfer
• Partner with NPI groups to ensure seamless transition from development builds through production qualification and commercial readiness.
• Direct comprehensive drawing reviews with cross-functional partners ensuring all Critical Dimensions are accounted for incoming and in-process inspections.
• Lead cross-functional teams through high-pressure production holds and scale-up challenges during NPI commercialization.
• Strategize and guide engineering teams to deploy effective investigation approaches for supplier and manufacturing issues.
• Proactively identify production risks during scale-up and drive containment/resolution before they impact launch timelines.

Statistical Analysis & Data-Driven Decision Making

• Perform statistical analyses including hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, and GR&R using Minitab.
• Utilize statistical process control (SPC), I-MR charts, Box plots, and Normality & Non-Normal tests to make quality decisions.
• Leverage data-driven approaches to inform process development decisions and validate process characterizations.
• Generate process capability reports to support production readiness decisions

Education & Experience Required:

• Master's degree in Mechanical Engineering, Biomedical Engineering, or related field AND 5+ years of experience in process development or manufacturing engineering for medical devices

OR

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related engineering field AND 7+ years of experience in process development or manufacturing engineering for medical devices

Highly Desired Qualifications

• 7+ years creating and/or overseeing complex IQ/OQ/PQ and TMV strategies for medical devices.
• Mastery of ISO 14971 and pFMEA with a clear track record of linking process risks to design controls.
• Strong working knowledge of statistical methods (DOEs, capability studies, Gage R&R) used in manufacturing.
• Solid working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485.
• Demonstrated experience exercising high-level professional discretion, influencing cross-functional peers, and guiding technical root cause investigations.
• Demonstrated experience in supporting low- to mid-volume electromechanical production lines or wearable medical devices.
• CQE (Certified Quality Engineer) or Six Sigma Black Belt certification

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.

Salary ranges for U.S (excl. PR) locations (USD):$109,000.00-$185,000.00

For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $121,000.00-$205,000.00 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.