Hands-On Reliability Engineer II: Medical-Device Testing & QA

MiniMed; Los Angeles (CA); Vor Ort; USD 76.000 - 128.000; Vollzeit

Zusammenfassung

MiniMed in Northridge, CA is seeking a Reliability Engineer II to lead test strategies for insulin therapy systems, ensuring safety and reliability in real-world use.

You will apply DOE, hypothesis testing, and capability analysis, operate environmental chambers and lab equipment, and collaborate with Electrical, Software R&D, Systems, and Mechanical engineering to drive robust test methods and risk management deliverables.

Qualifikationen

• Bachelor's degree with 2+ years of relevant experience or 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
• Familiarity with quality system requirements, design controls, and good manufacturing practices in a regulated medical device or cGMP environment
• Experience with data acquisition software such as NI LabVIEW

Aufgaben

• Develop test strategies activities associated with a family of insulin therapy systems used by individuals to effectively manage Type 1 and Type 2 diabetes.
• Work within the broader test team to develop consistent test strategies and methods across different portions of product testing.
• 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
• Operate a broad spectrum of lab equipment, such as environmental chambers, smart scopes, signal generators, Instrons
• Work with key external functions (Electrical Engineering, Software R&D, Systems Engineering, Mechanical Engineering) to develop robust test methods, root cause issues in products and test methods, and improve product design
• Contribute to risk management deliverables like failure modes effects analysis (dFMEA/pFMEA) and identify potential patient hazards.

Kenntnisse

Statistical analysis

Lab testing

Technical documentation

Cross-functional collaboration

Ausbildung

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related

Tools

NI LabVIEW

SolidWorks

Jobbeschreibung

MiniMed in Northridge, CA is seeking a Reliability Engineer II to lead test strategies for insulin therapy systems, ensuring safety and reliability in real-world use.

You will apply DOE, hypothesis testing, and capability analysis, operate environmental chambers and lab equipment, and collaborate with Electrical, Software R&D, Systems, and Mechanical engineering to drive robust test methods and risk management deliverables.