ReliabilityEngineer

Prioritize candidates with medical device or regulated hardware experience, strong background in reliability engineering, HALT/HASS/ALT, and statistical modeling (Weibull, lognormal). 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. Responsibilities: Additional responsibilities for this position are as follows: Working with R&D, quality assurance and manufacturing teams to develop reliability requirements (including requirements cascade), develop and implement comprehensive reliability test plans for IVD medical devices that align with product development and production processes. 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. Writing test protocols, training personnel on test procedure, analyzing data and creating final reports. Conducting reliability tests and documenting results, including environmental, lifecycle, and accelerated aging tests, to evaluate product performance under different conditions and in compliance with relevant regulatory standards and guidelines. Analyzing test results and providing detailed reports, identifying areas for improvement and potential risks. Serving as the subject matter expert and technical representative for the reliability engineering function in project teams. Recommending design or test methods and statistical process control procedures for achieving required levels of product reliability. Leading and directing multiple projects in a fast-paced, cross-functional environment. Participating in design reviews and working with engineering to drive DFR (Design fo