Staff Reliability Engineer

Staff Reliability EngineerTekfortune is a fast-growing consulting firm specialized in permanent, contract & project-based staffing services for world's leading organizations in a broad range of industries. In this quickly changing economic landscape, virtual recruiting and remote work are critical for the future of work. To support the active project demands and skills gaps, our staffing experts can help you find the best job for you.Location: San Jose, CA (Onsite 5 days in a week) Fulltime / Direct Hire Keywords: Accelerated Life testing (ALT or HALT), Weibull Analysis, Bath-tub curve prediction, RAMS (Reliability & Maintenance), ReliaSoft or Relyence Software exposure.Job DescriptionAs a Staff Reliability Quality Engineer to ensure product reliability and quality within a complex medical device product through the development and execution of product reliability test plan by way of verification procedure based upon product and design specifications. This role will partner closely with R&D, Systems Engineering, Manufacturing, and Quality teams to ensure highly reliable robotic medical systems are designed, verified, and launched successfully.What Your Day-To-Day Will InvolveLead system-level reliability strategy and testing for complex electromechanical medical devices, ensuring robust product performance across the design lifecycleApply advanced reliability engineering tools and methodologies such as Weibull analysis, Reliability Modeling, Fault Tree Analysis, Accelerated Life Testing (ALT), HALT/HASS, and structured root cause analysis to drive data-based design decisionsDefine reliability requirements, reliability growth plans, and reliability demonstration strategies for NPI programs and sustaining design changes; devise test protocols and write test reportsDesign and execute reliability test protocols for mechanical, electrical, environmental, and software-driven subsystems across system, subsystem, and component levels.Partner with Systems Engineering and R&D to ensure proper linkage between design requirements, risk management, reliability verification, and validation activities.Drive reliability insights through analysis of field data, complaint trends, and nonconformance data to support product improvements and risk mitigation.Collaborate cross-functionally with R&D, Manufacturing Engineering, Supplier Quality, Regulatory Affairs, and Failure Analysis teams to resolve reliability issues and improve product robustnessDevelop and implement reliability testing infrastructure, including custom fixtures and automated test setupsChampion a data-driven reliability culture by mentoring engineers and promoting best practices in reliability engineering and statistical analysisEnsure compliance with ISO 13485, FDA Quality System Regulations (21 CFR 820), and applicable regulatory standardsUnderstand and adhere to the PROCEPT BioRobotics EHS policyThe Qualifications We Need You to PossessBachelor's or Master's degree in engineering (e.g. Biomedical/Electrical/Mechanical)5+ years of experience working in medical device or equivalent regulated industry demonstrative of Reliability expertise.Background in Capital Equipment and/or complex electromechanical and embedded software devices.Experience defining and executing Accelerated Life Testing (ALT), HALT/HASS, and reliability verification strategies.Perform reliability prediction analyses using established industry standards such as MIL-HDBK-217, Telcordia, and FIDES.Maintain automated testing frameworks using Python and C++ to perform testing.Strong analytical, problem-solving, statistical analysis and communication skills with the ability to influence cross-functional engineering teams.The Qualifications We Would Like You to PossessASQ CQE, or CRE certification preferredBasic machine tool and manufacturing experience a plusExperience with medical device testing or development a plus.For more information and other jobs available please contact our recruitment team at View email address on click.appcast.io.