Onsite Product Verification Engineer II (Medical Devices)

USA-Medtronic MiniMed, Inc 1017; Los Angeles (CA); Sur place; USD 68 000 - 116 000; Plein temps

Résumé du poste

MiniMed in Northridge, CA is hiring a Product Test Engineer II to lead verification strategies for next-generation infusion pump systems. You will work across R&D, Quality, and Operations to develop robust test methods, analyze results, and document findings ensuring safety and performance in real-world use.

The role emphasizes hands-on lab work, data-driven validation, and collaboration with cross-functional teams to drive design improvements respecting FDA/regulatory standards.

Qualifications

• Bachelor's degree in Biomedical or Mechanical Engineering; 2+ years of relevant experience, or advanced degree with 0+ years.
• Direct experience with technical documentation including engineering reports, SOPs, test protocols, and lab notebooks.

Responsabilités

• Develop and execute design verification and test strategies for electromechanical medical device programs with cross-functional teams.
• Develop test methods to exercise products against simulated use environments across real-world conditions.
• Apply statistical techniques (hypothesis testing, DOE, regression, capability analysis) to support test method validation and reliability activities.
• Contribute to DFMEA/PFMEA and Hazard Analysis and support test methodologies to address essential design outputs.
• Author and maintain test protocols, engineering reports, SOPs, and lab notebooks.
• Support CAPA investigations, post-market analysis, and regulatory audit activities as needed.

Connaissances

Design verification

Test strategy development

Statistical analysis

Risk management

Technical documentation

Formation

Biomedical/Mechanical Engineering degree

Advanced degree (optional)

Outils

MATLAB

Minitab

Weibull++

NI LabVIEW

SolidWorks

Description du poste

MiniMed in Northridge, CA is hiring a Product Test Engineer II to lead verification strategies for next-generation infusion pump systems. You will work across R&D, Quality, and Operations to develop robust test methods, analyze results, and document findings ensuring safety and performance in real-world use.

The role emphasizes hands-on lab work, data-driven validation, and collaboration with cross-functional teams to drive design improvements respecting FDA/regulatory standards.