Shape the future of IVD medical devices as a Senior Reliability Engineer. Leverage your expertise in statistical modeling, reliability engineering, and regulatory compliance while collaborating with cross-functional teams.
This role requires a strong background in reliability engineering, particularly within regulated hardware or medical devices. You will lead DFMEA efforts, develop reliability test plans, and ensure adherence to ISO standards. Your skills in tools like Minitab and Python will be key as you design tests, analyze data, and recommend improvements for device performance.
Key Responsibilities:
• Develop reliability requirements in collaboration with R&D and QA
• Lead Design Failure Mode and Effects Analysis (DFMEA) efforts
• Design test methods and fixtures for IVD devices
• Write test protocols and analyze data for performance evaluation
• Conduct reliability tests, documenting results and compliance
Requirements:
• Bachelor’s degree in Engineer...