Sapsol Technologies INC 7

Sapsol Technologies INC 7

Reliability Engineer

Canada

Sponsorship not specifiedDetected 50 days ago
PythonMATLABData AnalysisStatisticsFDA RegulatoryMedical Devices

About the role

  • Prioritize candidates with medical device or regulated hardware experience, strong background in reliability engineering, HALT/HASS/ALT, and statistical modeling (Weibull, lognormal).
  • Writing test protocols, training personnel on test procedure, analyzing data and creating final reports.

Responsibilities

  • Developing reliability plans and requirements, leading and facilitating Design Failure Mode and Effects Analysis (DFMEA).
  • Designing and developing test methods and fixtures to assess the performance and durability of IVD devices.
  • Participating in design reviews and working with engineering to drive DFR (Design for Reliability) process and tools and support in defining and executing reliability plans.

Requirements

  • Recommending design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • You have a strong understanding of engineering principles and are familiar with relevant software and tools.
  • Required skills to have for the success of this role.
  • You can communicate effectively with other engineers, managers, and stakeholders.
  • You can identify and assess risks that can cause delays to project timelines or increase project costs.

Nice to have

  • Technical Evaluation - Assess expertise in DFMEA/PFMEA, fault tree analysis, accelerated life testing, DOE, and use of data tools (Minitab/JMP required
  • Python/Matlab/R preferred).
  • Regulatory Knowledge - Verify familiarity with ISO 13485, ISO 14971, FDA 21 CFR 820, EU MDR/IVDR, IEC 60601, IEC 62304, IEC 62366‑1, ISO 10993, and ISO 17025.
  • Bachelor's degree (Advanced degree preferred) in Mechanical /Electrical /Reliability Engineering or related discipline.

Benefits

  • You have a working knowledge of regulations and best practices for medical device development such as ISO 13485 and 21 CFR 820 as well as IEC 61010, IEC 60601, IEC 62506, IEEE 1413 and IEEE 1332.
  • You have knowledge of building fixtures and performing Life Data Analysis for in-vitro diagnostics medical products.
  • 10+ years reliability engineering experience in highly regulated industry preferably in a medical device industry.
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