Staff Reliability Engineer

Gulf Coast Automation Group•San Jose, CA

2d•Onsite

About The Position

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. The Staff Reliability Engineer will lead system-level reliability strategy and testing for complex electromechanical medical devices, ensuring robust product performance across the design lifecycle. They will 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. This role involves defining reliability requirements, reliability growth plans, and reliability demonstration strategies for NPI programs and sustaining design changes, as well as devising test protocols and writing test reports. The engineer will design and execute reliability test protocols for mechanical, electrical, environmental, and software-driven subsystems across system, subsystem, and component levels. They will partner with Systems Engineering and R&D to ensure proper linkage between design requirements, risk management, reliability verification, and validation activities. The position drives reliability insights through analysis of field data, complaint trends, and nonconformance data to support product improvements and risk mitigation. Collaboration with R&D, Manufacturing Engineering, Supplier Quality, Regulatory Affairs, and Failure Analysis teams is crucial for resolving reliability issues and improving product robustness. The role also involves developing and implementing reliability testing infrastructure, including custom fixtures and automated test setups, and championing a data-driven reliability culture by mentoring engineers and promoting best practices in reliability engineering and statistical analysis. Ensuring compliance with ISO 13485, FDA Quality System Regulations (21 CFR 820), and applicable regulatory standards is also a key responsibility.

Requirements

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

Nice To Haves

ASQ CQE, or CRE certification preferred
Basic machine tool and manufacturing experience a plus
Experience with medical device testing or development a plus

Responsibilities

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
Maintain trained status for and comply with all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance
Understand and adhere to the PROCEPT BioRobotics Quality & EHS policies