Product Test Engineer II - Medical Device Verification

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

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.