Product Test Engineer II

USA-MiniMed Distribution Corp. 1018; Los Angeles (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

MiniMed in Northridge, CA seeks a Product Test Engineer II to ensure next-generation infusion pump systems meet the highest standards of safety, quality, and performance. You will drive test strategies, execute verification activities, and work with R&D and operations to validate products under real‑world conditions.

The role combines hands‑on lab work with data analysis, documentation, and contribution to risk management.

Qualifications

• Bachelor's degree in Biomedical Engineering or closely related field with 2+ years of relevant experience.
• Experience documenting engineering reports, SOPs, test protocols, and lab notebooks.
• Experience in design verification testing and test method validation.
• Familiarity with FDA-regulated medical devices and quality systems is a plus.

Responsibilities

• Develop and execute design verification and test strategies for electromechanical medical device programs, working closely with cross‑functional teams from design planning through design transfer.
• Develop test methods to exercise products against simulated use environments, ensuring products perform safely across various real‑world conditions.
• Apply statistical techniques such as hypothesis testing, DOE, regression, and capability analysis to support test method validation, design characterization, root cause analysis, and reliability demonstration activities.
• Contribute to risk management deliverables, including DFMEA/PFMEA and Hazard Analysis, and support test methodologies to address essential design outputs.
• Author and maintain technical documentation, including 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 audit activities as needed.

Skills

Test strategy development

Statistical analysis

DOE

CAPA investigations

Education

Bachelor's degree in Biomedical Engineering

Tools

MATLAB

Minitab

Weibull++

NI LabVIEW

SolidWorks

Job description

We anticipate the application window for this opening will close on - 5 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

At MiniMed, we build technology that millions of people living with Type 1 and Type 2 diabetes trust with their health every single day. As a Product Test Engineer II you will play an important 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 R&D collaboration - making it an exciting opportunity for engineers who thrive on both technical depth and cross-functional partnership.

In this hands-on and highly collaborative role, you will develop and execute test strategies and methods that put our insulin therapy systems through their paces - simulating real‑world environments to validate that our products perform safely and reliably when patients need them most. You will work alongside experienced engineers and cross‑functional partners to support verification testing for current programs while gaining exposure to new designs and emerging technologies, including novel delivery algorithms and next‑generation pump architectures.

Your technical contributions - from applying statistical techniques and operating lab equipment to authoring test protocols and engineering reports - will directly influence product safety and design quality. If you are a curious, detail‑driven engineer who thrives in a hands‑on lab environment and wants your work to truly make a difference, this is the role for you.

This is an onsite role at our Northridge, CA location.

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

• Develop and execute design verification and test strategies for electromechanical medical device programs, working closely with cross‑functional teams from design planning through design transfer.
• Develop test methods to exercise products against simulated use environments, ensuring products perform safely across various real‑world conditions.
• Apply statistical techniques such as hypothesis testing, DOE, regression, and capability analysis to support test method validation, design characterization, root cause analysis, and reliability demonstration activities, including compiling and analyzing performance reports, process control statistics, and relevant variables affecting product and process performance.
• Contribute to risk management deliverables, including DFMEA/PFMEA and Hazard Analysis, and support the development of test methodologies to address essential design outputs.
• Author and maintain technical documentation, including 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 audit activities as needed.

Must Have: Minimum Requirements

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

Nice to Have (Preferred Qualifications)

• Experience working 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 applicable 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 (5‑Why, Fishbone, 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 with the ability to collaborate effectively across cross‑functional teams (R&D, Ops, Regulatory, Quality).
• Self‑starter with strong organizational skills, ability to prioritize, and a sharp focus on quality and customer experience.

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