Senior Reliability Engineer Medical Devices
Employment International
Join a leading team as a Senior Reliability Engineer focused on medical devices. Utilize your expertise in reliability engineering to enhance product quality and safety in a regulated environment. We are seeking a Senior Reliability Engineer with over 10 years of experience for our Medical Device division. This strategic role requires proficiency in reliability engineering principles and technical regulations. Key responsibilities include leading reliability projects, conducting life testing, and developing custom testing tools to ensure the safety of our medical products. Key Responsibilities:
- Lead reliability engineering for regulated hardware
- Conduct DFR and various life testing methodologies
- Perform DFMEA, PFMEA, and Fault Tree Analysis
- Execute Weibull analysis for reliability assessments
- Develop custom testing tools and verification systems
- 10+ years in Medical Device/MedTech experience
- Strong reliability engineering background with relevant techniques
- Hands-on skills with Minitab and/or JMP software
- Knowledge of ISO 13485, ISO 14971, FDA regulations
- Familiarity with reliability testing protocols and standards
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