Product Test Engineer II

MiniMed•Northridge, CA

3d•Onsite

About The Position

The Product Test Engineer II supports verification of current medical-device programs and contributes to the development of next-generation infusion pump systems. The role works across product verification, reliability engineering, and R&D, developing and executing test strategies and methods that simulate real-world use and assess product safety and reliability. The position is hands-on and lab-based, with collaboration across engineering and other functions from design planning through design transfer. Work may include exposure to emerging technologies, novel delivery algorithms, and next-generation pump architectures. Technical contributions include statistical analysis, laboratory testing, test protocol development, and engineering reporting. The role is onsite at MiniMed’s Northridge, California facility the majority of the time, with some flexibility for hybrid work.

Requirements

Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a closely related engineering discipline with at least 2 years of relevant experience, or an advanced degree with at least 0 years of relevant experience.
Direct experience with technical documentation, including engineering reports, standard operating procedures, test protocols, and laboratory or engineering notebooks.

Nice To Haves

Experience in an FDA-regulated or similarly regulated medical-device or cGMP environment.
Familiarity with quality-system requirements, design controls, and good manufacturing practices.
Working knowledge of standards such as 21 CFR 820, IEC 60601-1, IEC 60601-2-24, ISO 13485, ISO 11608, and ISO 14971.
Hands-on experience with design verification testing, test-method development, and test-method validation.
Familiarity with root-cause analysis tools such as 5-Why, Fishbone, and Fault Tree.
Proficiency with statistical analysis tools such as MATLAB, Minitab, or Weibull++.
Experience with data-acquisition software such as NI LabVIEW.
Experience with fixture design, prototyping, 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 and ability to collaborate across R&D, Operations, Regulatory, and Quality teams.
Self-starter with strong organizational skills, ability to prioritize, and a focus on quality and customer experience.

Responsibilities

Develop and execute design verification and test strategies for electromechanical medical-device programs in collaboration with cross-functional teams, from design planning through design transfer.
Develop test methods that exercise products in simulated-use environments and assess safe performance across real-world conditions.
Apply statistical techniques, including hypothesis testing, design of experiments, regression, and capability analysis, to support test-method validation, design characterization, root-cause analysis, and reliability demonstrations.
Compile and analyze performance reports, process-control statistics, and variables affecting product and process performance.
Contribute to risk-management deliverables, including DFMEA, PFMEA, and Hazard Analysis, and support test methodologies addressing essential design outputs.
Author and maintain test protocols, engineering reports, standard operating procedures, and laboratory notebooks.
Participate on project teams, support change-control evaluations, and contribute to quality decisions across engineering groups.
Support CAPA investigations, post-market analysis, and regulatory audits as needed.