Reliability Engineer IVD Devices

Position: Reliability Engineer for IVD Devices
Engage in a rewarding role as a Reliability Engineer focused on IVD medical devices. Bring your reliability engineering expertise to manage complex product evaluations and testing.

In this role, you will apply over ten years of experience in reliability engineering in a highly regulated setting. Collaborating with R&D and manufacturing teams, you will develop reliability requirements and conduct rigorous testing to ensure product compliance with frameworks like ISO 13485 and IEC standards. Your skills in statistical analysis will enable you to assess test results and recommend critical improvements in device design.

Key Responsibilities:

• Develop and implement reliability test plans for in-vitro diagnostics

• Analyze and report on test data with clarity and depth

• Guide DFMEA activities and conduct fault analysis

• Create test fixtures and protocols for performance evaluations

• Assess risks and suggest methods for reliability enhancement

Requirements:

• Degree in Engineering; advanced degree preferred

• 10+ years of relevant experience in medical device industry

• Strong knowledge of FDA and ISO regulations

• Proficiency in Minitab and statistical modeling tools

• Skilled in managing multiple engineering projects

Leverage your expertise in reliability engineering to influence the future of medical device innovation.
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