Senior Product Test Engineer

MiniMed•Northridge, CA

1d•Hybrid

About The Position

As a Senior Product 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 on the technical career stream, you will formulate, deliver, and manage assigned projects while working with cross-functional stakeholders to achieve desired results. You will not only lead verification and reliability testing for current programs but will also be deeply embedded with R&D partners to characterize new designs and emerging technologies — including novel delivery algorithms, next-generation pump architectures, and performance testing for products still under development. The majority of your time will be spent advancing existing and new technologies from design to implementation, applying specialized knowledge and skills while adhering to established policies. This position is part of the Mechanical Engineering department; a team committed to improving the lives of people within the global diabetes community. 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.

Requirements

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
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.

Nice To Haves

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

Responsibilities

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