Staff Reliability Engineer
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 Description:
As 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 Involve:
- Lead system-level reliability strategy and testing for complex electromechanical medical devices, ensuring robust product performance across the design lifecycle
- Apply 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 decisions
- Define reliability requirements, reliability growth plans, and reliability demonstration strategies for NPI programs and sustaining design changes ; devise test protocols and write test reports
- Design 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 robustness
- Develop and implement reliability testing infrastructure, including custom fixtures and automated test setups
- Champion a data-driven reliability culture by mentoring engineers and promoting best practices in reliability engineering and statistical analysis
- Ensure compliance with ISO 13485, FDA Quality System Regulations (21 CFR 820), and applicable regulatory standards
- Understand and adhere to the PROCEPT BioRobotics EHS policy
The Qualifications We Need You to Possess
- Bachelor 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 Possess
- ASQ CQE, or CRE certification preferred
- Basic machine tool and manufacturing experience a plus
- Experience with medical device testing or development a plus.
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