Senior Reliability Engineer Medical Devices

Elevate your career as a Senior Reliability Engineer in the Medical Device sector with 10+ years of experience. This role focuses on reliability engineering for regulated hardware products.

Join a leading company seeking a seasoned professional with extensive Medical Device/Med Tech experience. You will utilize your core reliability engineering skills to improve regulated hardware products, particularly IVD devices. Responsibilities include implementing DFR, conducting various testing methodologies, and ensuring compliance with established standards like ISO 13485 and FDA regulations.

Key Responsibilities:

• Develop reliability engineering processes for IVD medical devices

• Conduct HALT, HASS, ALT, and other accelerated life testing

• Perform DFMEA, PFMEA, and Fault Tree Analysis (FTA)

• Utilize Weibull and life data analysis to assess product reliability

• Create custom test fixtures and verification testing protocols

Requirements:

• 10+ years of experience in Medical Device/Med Tech

• Strong knowledge of core reliability engineering principles

• Proficient in Minitab and/or JMP software

• Familiar with ISO 13485, ISO 14971, FDA 21 CFR 820

• Hands-on experience with reliability testing methods

Utilize your expertise in reliability engineering to enhance medical device products and contribute to industry advancement.
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