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Reliability Engineer

1 week ago
Canada
Contract
Lead
Site Reliability Engineer (SRE)
DevOps and Infrastructure
MATLAB Python R
Apply Now
Sapsol Technologies

Sapsol Technologies

Sapsol Technologies specializes in innovative business transformation by integrating ERP systems, AI, cloud computing, and DevOps, with a focus on S/4HANA implementation, system migration, and managed support services to optimize business processes and...

Internet Software & Services
51-250
Founded 2006
View All Jobs 25

Description

  • Work with R&D, quality assurance, and manufacturing teams to define reliability requirements and cascade them through product development.
  • Develop and implement reliability test plans aligned with product development and production processes for IVD medical devices.
  • Lead and facilitate DFMEA activities and support design reviews with engineering teams.
  • Design test methods and build fixtures to evaluate product performance, durability, and reliability.
  • Write test protocols, train personnel on test procedures, analyze data, and produce final reports.
  • Conduct environmental, lifecycle, and accelerated aging tests and document results in compliance with regulatory standards.
  • Review device failures, perform root cause investigations, and document findings in FRACAS systems.
  • Analyze test results, performance reports, and process control statistics to identify risks and areas for improvement.
  • Serve as the reliability engineering subject matter expert on cross-functional project teams.
  • Lead multiple projects in a fast-paced environment and support DFR processes and reliability planning.

Requirements

  • Bachelor’s degree in Mechanical, Electrical, Reliability Engineering, or a related discipline; advanced degree preferred.
  • 10+ years of reliability engineering experience in a highly regulated industry, preferably medical devices.
  • Experience with medical device or regulated hardware development.
  • Strong background in reliability engineering, HALT/HASS/ALT, and life data analysis.
  • Experience with DFMEA, PFMEA, fault tree analysis, accelerated life testing, and Design of Experiments (DoE).
  • Experience creating custom verification tests and fixtures, including sample size selection for verification planning.
  • Proficiency with Minitab or JMP; Python, Matlab, or R preferred.
  • Experience with reliability and statistical analysis software such as ReliaSoft and PTC Windchill.
  • Working knowledge of ISO 13485 and FDA 21 CFR 820; familiarity with EU MDR/IVDR, IEC 60601, IEC 62323/62366-1, ISO 10993, ISO 17025, IEC 61010, IEC 62506, IEEE 1413, and IEEE 1332.
  • Strong communication, collaboration, problem-solving, and multi-project prioritization skills.

Interested in this position?

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