MedTech Product Reliability Engineer

Location: Greater Sudbury

Join the Med Tech industry as a Reliability Engineer in Ottawa, Ontario, focusing on IVD product reliability. This senior-level position requires substantial experience in regulated hardware product development.

As a Senior Reliability Engineer, you will bring 10+ years of specialized experience in medical devices to our team. Your expertise in reliability engineering will be critical for designing and executing test methods, leading risk assessments, and conducting thorough data analysis. Collaborating with R&D and quality teams, you will aim to enhance product reliability and regulatory compliance.

Key Responsibilities:

• Lead the development of reliability requirements for IVD devices

• Conduct DFMEA and PFMEA assessments

• Implement HALT, HASS, and lifecycle tests

• Analyze life data and prepare reports for stakeholders

• Drive collaboration to ensure compliance with standards

Requirements:

• 10+ years in product reliability engineering (Med Tech)

• Deep knowledge of DFMEA, FTA, and HALT testing

• Skilled in life data analysis techniques

• Familiarity with ISO 13485 and FDA 21 CFR 820

• Experience in designing test fixtures and validation practices

Utilize your reliability engineering skills to contribute to the development of innovative IVD medical devices.
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