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Senior Reliability Engineer in MedTech

Infostride

Drive innovation in the MedTech field as a Senior Reliability Engineer in Ottawa, Ontario. Your expertise will ensure the reliability of IVD products through rigorous testing and analysis. As a Senior Reliability Engineer, you will leverage over 10 years of experience in medical device reliability. This role involves leading risk assessments and developing compliance strategies while collaborating with R&D and quality teams. Your mission is to enhance product reliability, ensuring that IVD devices meet stringent regulatory standards. Key Responsibilities:

  • Lead the development of reliability requirements for IVD devices
  • Conduct DFMEA and PFMEA assessments effectively
  • Implement HALT, HASS, and lifecycle testing methods
  • Analyze life data and report findings to stakeholders
  • Collaborate to ensure compliance with industry standards
Requirements:
  • Over 10 years in product reliability engineering for MedTech
  • Expertise in DFMEA, FTA, and HALT testing methodologies
  • Proficient in life data analysis techniques
  • Familiarity with ISO 13485 and FDA 21 CFR 820
  • Experience in designing test fixtures and validation processes
Contribute your reliability engineering expertise to shape innovative IVD medical devices. #J-18808-Ljbffr

Vacancy posted 5 hours ago
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