Staff Reliability Engineer

PROCEPT BioRobotics•San Jose, CA

2d•$154,280 - $181,500

About The Position

Join PROCEPT BioRobotics as a Reliability Quality Engineer to ensure product reliability and quality within a complex medical device product. This role involves developing and executing product reliability test plans through verification procedures based on product and design specifications. You 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. PROCEPT BioRobotics is committed to revolutionizing treatment for benign prostatic hyperplasia (BPH) through innovation in surgical robotics, improving patient quality of life, providing effective treatment options for surgeons, and upholding shareholder trust. The company fosters a culture where every person matters, encouraging innovation, humility, engagement, and seamless teamwork. They offer a work-life blend and an opportunity to join a community devoted to making a difference.

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.