Senior Product Test 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

Due to the hands-on, lab-based nature of this role, on-site presence at our Northridge, CA facility is required the majority of the time, with some flexibility for hybrid work.

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

• Lead planning and execution of design verification and reliability test strategies for electromechanical medical device programs, from design planning through design transfer, working closely with cross-functional teams
• Collaborate with product development teams, such as mechanical, electrical, systems, firmware, and software engineering, to characterize new hardware designs, novel delivery algorithms, and emerging technologies across electro-mechanical, electro-chemical, and software/algorithm interfaces
• Apply statistical techniques such as hypothesis testing, DOE, regression, and capability analysis to support test method validation, design characterization, root cause analysis, and verification and reliability demonstration activities
• Review risk management deliverables including DFMEA/PFMEA and Hazard Analysis in collaboration with design quality, post-market quality, and medical safety functions, and develop test methodologies to address essential design outputs
• Participate on project teams and technical review boards, lead change control evaluations, and coordinate quality decisions across engineering groups
• Lead CAPA projects, support post-market analysis, and participate in internal and external regulatory audits

Must Have: Minimum Requirements

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

• Bachelor’s degree in engineering or science with 4+ years of work experience in medical device development and/or development quality OR Master’s Degree in Engineering or Science with 2+ years of work experience in medical device development and/or development quality

Nice to Have (Preferred Qualifications)

• Bachelor's degree in Biomedical, Mechanical, Chemical, or Electrical Engineering; Master's degree in Engineering, Quality, or Regulatory preferred
• Experience working in an FDA-regulated or similarly regulated industry
• Working knowledge of 21 CFR 820, IEC 60601-1, IEC 60601-2-24, IEC 62304, ISO 13485, and ISO 14971
• Hands-on experience with design verification testing, test method development, and test method validation
• Understanding of the interdependencies of program work products and guide the teams in execution strategy and reviewing the program work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports). 
• Experience with DFMEA, Accelerated Life Testing, Reliability Growth, and Demonstration Testing
• Proficiency with statistical analysis tools such as MATLAB, Minitab, or Weibull++
• Experience with data acquisition software such as NI LabVIEW
• Experience with fixture design and 3D modeling tools such as SolidWorks
• Working knowledge of electromechanical devices, battery-powered devices, and/or electrochemical reactions
• Strong written and verbal communication skills with the ability to effectively communicate at multiple hierarchal levels in the organization.
• Ability to multi-task, prioritize, meets/exceed deadlines and holds themselves, and others accountable.
• Self-starter with strong organizational skills, ability to prioritize, and a sharp focus on quality and customer experience.

#BetterDaysStartNow

Physical Job Requirements

The physical demands of this role are representative of those that must be met to successfully perform its essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Due to the hands-on, lab-based nature of this role, on-site presence at our Northridge, CA facility is required the majority of the time, with some flexibility for hybrid work.

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 $97,000 - $165,000.

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.