Principal Test Engineer

MiniMed•Northridge, CA

2d•$109,000 - $185,000•Hybrid

About The Position

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 As a Principal Test Engineer within the Product Design Verification & Reliability Engineering group, you will play a pivotal role in ensuring that next-generation infusion pump systems meet the highest standards of quality, safety, and performance. This role sits at the intersection of product verification, reliability engineering, and early-stage R&D collaboration — making it an exciting opportunity for engineers who thrive on both technical depth and cross-functional partnership. As an individual contributor, you will be responsible for developing and implementing comprehensive test strategies for electromechanical medical device programs, ensuring products are reliable, safe, and effective for their intended use. You will partner with project leads and R&D partners to drive program success by leading verification and reliability testing, characterizing new designs and emerging technologies (including novel delivery algorithms and next-generation pump architectures), supporting sustaining engineering efforts, and contributing to the development of larger program schedules and strategies, ultimately expanding global access to MiniMed products.

Requirements

Bachelor’s degree in engineering with a minimum of 7 years of work experience in medical device development OR an advanced degree with a minimum of 5 years of work experience in medical device development

Nice To Haves

Bachelor's degree in Mechanical, Biomedical, or Electrical Engineering or Physics; Master's degree in Engineering, Physics, 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).
Strong technical communication skills, sound judgment, accountability for results, the ability to interpret complex data and manage multiple priorities effectively and effectively communicate at multiple hierarchal levels in the organization.
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
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.

Responsibilities

Lead design verification and reliability testing 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
Lead CAPA projects, support post-market analysis, and participate in internal and external regulatory audits
Mentor junior engineers and foster a culture of technical excellence, innovation, and professional growth.