Principal Engineer - Product Testing

MiniMed; Los Angeles (CA); Presencial; USD 109.000 - 205.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, dental, vision insurance

401(k) with company match

Paid time off

Descripción de la vacante

MiniMed is seeking a highly specialized expert to own and lead pressure decay leak test systems and related test design across manufacturing lines. You will act as the technical authority ensuring testing processes deliver reliable, compliant results throughout production.

The role requires designing, validating, and optimizing test equipment, collaborating with R&D, Quality, and Regulatory teams, and driving continuous improvement. On-site in Northridge, CA with 25–40% travel.

Formación

• Must have: Bachelor’s degree with 7+ years of relevant experience or Advanced degree with 5+ years of relevant experience.
• Experience with alternative leak test methodologies (mass flow, helium, vacuum decay).
• Experience with industry-leading leak test equipment (Uson, Zaxis, Inficon or equivalent).
• Experience with medical device manufacturing, process validation, quality systems, and regulatory requirements.
• Experience with root cause analysis, statistical methods, and manufacturing process optimization.

Responsabilidades

• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Designs sequence of operations and specifies procedures for fabrication of tools and equipment.
• Adapts machine or equipment design to factory and production conditions.
• Develops manufacturing processes applicable to statistical process control and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements.
• Leads the process development, qualification and validation of test equipment (IQ/OQ/PQ) in compliance with FDA and ISO regulations.
• Defines test specifications, acceptance criteria, and test parameters in collaboration with R&D, Quality, and Regulatory teams.
• Troubleshoots and resolves complex test failures, driving root cause analysis and implementing sustainable corrective actions.
• Evaluates and recommends new test technologies and methodologies to enhance test capability and manufacturing efficiency.
• Develops and executes test method validation studies, including repeatability, reproducibility, and measurement system analysis (Gauge R&R/TMV).
• Incorporates inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Drives continuous improvement initiatives to optimize test yield, cycle time, and false rejection rates.
• Analyzes manufacturing performance metrics like LBM, yield, capacity and develop action plans to improve throughput, efficiency, and overall equipment effectiveness (OEE).

Conocimientos

Pressure decay leak testing

Test system design

Root cause analysis

Statistical methods

Process optimization

Project leadership

Educación

Bachelor's degree in engineering or related field

Advanced degree in engineering or related field

Herramientas

Uson equipment

Zaxis equipment

Inficon equipment

Descripción del empleo

We anticipate the application window for this opening will close on - 20 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

We are seeking a highly specialized subject matter expert to own and lead all aspects of pressure decay leak test systems and transmission test design, implementation, validation, and optimization across our manufacturing lines. In this pivotal role, you will serve as the technical authority ensuring our testing processes deliver consistent, reliable, and compliant results at every stage of production.

In this role, you will serve as the primary subject matter expert for pressure decay leak test system and electrical/mechanical test systems’ design, implementation, validation, and optimization across manufacturing lines.

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

Full-time on-site role in Northridge, CA with willingness and ability to travel for business 25-40% of the time depending on project needs

• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment that affect product performance.
• Adapts machine or equipment design to factory and production conditions.
• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Leads the process development, qualification and validation of test equipment (IQ/OQ/PQ) in compliance with FDA and ISO regulations
• Defines test specifications, acceptance criteria, and test parameters in collaboration with R&D, Quality, and Regulatory teams
• Troubleshoots and resolves complex test failures, driving root cause analysis and implementing sustainable corrective actions
• Evaluates and recommends new test technologies and methodologies to enhance test capability and manufacturing efficiency
• Develops and executes test method validation studies, including repeatability, reproducibility, and measurement system analysis (Gauge R&R/TMV)
• Incorporates inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Drives continuous improvement initiatives to optimize test yield, cycle time, and false rejection rates
• Analyzes manufacturing performance metrics like LBM, yield, capacity and develop action plans to improve throughput, efficiency, and overall equipment effectiveness (OEE).

Must Have: Minimum Requirements

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

• Bachelor’s degree with minimum of 7+ years of relevant experience, or Advanced degree with a minimum of 5+ years of relevant experience.
• Experience with alternative leak test methodologies (e.g., mass flow, helium, vacuum decay)
• Experience with industry-leading leak test equipment (e.g., Uson, Zaxis, Inficon, or equivalent)
• Experience with medical device manufacturing, process validation, quality systems, and regulatory requirements
• Experience with root cause analysis, statistical methods, and manufacturing process optimization.

Nice To Have:

• Demonstrated experience for owning technical strategy, operational performance, and optimization of production process for long term sustainability
• Familiarity with MES (Manufacturing Execution Systems) integration with test equipment
• Experience with fluid dynamics, pneumatics, and hermetic sealing principles
• Experience supporting Contract Manufacturers in a medical device environment
• Six Sigma Green Belt or Black Belt certification
• Experience with pump or infusion device manufacturing

#BetterDaysStartNow

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 - $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.