Lead System-Level Reliability: Drive reliability strategy and testing for complex electromechanical medical devices, ensuring robust product performance across the design lifecycle.Apply Advanced Methodologies: Utilize reliability engineering tools 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 decisions.Define Requirements: Establish reliability requirements, reliability growth plans, and demonstration strategies for NPI (New Product Introduction) programs and sustaining design changes; devise test protocols and author comprehensive test reports.Execute Testing: Design and execute reliability test protocols for mechanical, electrical, environmental, and software-driven subsystems across system, subsystem, and component levels.Cross-Functional Partnership: Partner with Systems Engineering and R&D to ensure proper linkage between design requirements, risk management, reliability verification, and validation activities.Analyze Field Data: Drive reliability insights through the analysis of field data, complaint trends, and nonconformance data to support product improvements and risk mitigation.Collaborate on Robustness: Work alongside R&D, Manufacturing Engineering, Supplier Quality, Regulatory Affairs, and Failure Analysis teams to resolve reliability issues.Build Infrastructure: Develop and implement reliability testing infrastructure, including custom fixtures and automated test setups.Champion Culture: Foster a data-driven reliability culture by mentoring engineers and promoting best practices in reliability engineering and statistical analysis.Maintain Compliance: Ensure alignment with ISO 13485, FDA Quality System Regulations (21 CFR 820), and applicable regulatory standards.EHS Alignment: Understand and adhere to the corporate Environmental Health and Safety (EHS) policy.
7-10 years
ASQ CQE (Certified Quality Engineer) or CRE (Certified Reliability Engineer) certification.Basic machine tool and manufacturing experience.
Education: Bachelor???s or Master???s degree in Engineering (e.g., Biomedical, Electrical, or Mechanical).Experience: 5+ years of experience in the medical device industry (or an equivalent regulated industry) demonstrating dedicated reliability expertise.Technical Domain: Strong background working with Capital Equipment, complex electromechanical systems, and embedded software devices.Testing Expertise: Proven experience defining and executing Accelerated Life Testing (ALT), HALT/HASS, and reliability verification strategies.Predictive Analysis: Experience performing reliability prediction analyses using established industry standards such as MIL-HDBK-217, Telcordia, and FIDES.Software Skills: Ability to maintain automated testing frameworks using Python and C++ to execute tests.Soft Skills: Strong analytical, problem-solving, and statistical analysis skills, with the communication clarity needed to influence cross-functional engineering teams.
Bachelors
We are here to help you with your questions.