Senior Reliability Engineer Medical Devices
Purple Hires
Elevate quality in medical devices as a Senior Reliability Engineer. Leverage your expertise in reliability engineering and regulatory compliance to drive innovation and excellence. As an Expert Reliability Engineer, you will focus on optimizing product quality for IVD devices. With over 10 years of experience, you'll develop reliability test strategies and work closely with teams to ensure adherence to ISO and FDA standards. Your skills in statistical modeling and software like JMP will be essential for effective test design and execution. Key Responsibilities:
- Lead development and execution of reliability test plans
- Conduct DFMEA and assess design risks
- Write and implement test protocols for IVD devices
- Perform reliability testing and analyze results
- Act as subject matter expert in project discussions
- Bachelor’s degree in Mechanical or Reliability Engineering
- Over 10 years of medical device reliability experience
- Strong knowledge of IEC and ISO regulations
- Familiarity with Minitab and reliability analysis tools
- Proven track record in leading complex projects
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