Reliability Quality Engineer

Company Overview

Embark on an enriching journey with PROCEPT Bio Robotics, where our vision, mission, and values guide everything we do. We are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH) through innovation in surgical robotics and to improving patient quality of life.

Join us as a Reliability Quality Engineer to ensure product reliability and quality within a complex medical device product through the development and execution of product reliability test plans and verification procedures based on product and design specifications.

• 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 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 Bio Robotics EHS policy.

• Bachelor’s or Master’s degree in engineering (e.g., Biomedical, Electrical, Mechanical).
• 5+ years of experience in medical device or equivalent regulated industry with demonstrable 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 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.

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

• Full medical coverage for employees and families.
• Wellness programs.
• On‑site gym.
• 401(k) plan with employer match.
• Short‑term and long‑term disability coverage.
• Basic life insurance.
• Wellbeing benefits.
• Flexible or paid time off.
• Paid parental leave.
• Paid holidays.

PROCEPT Bio Robotics is an equal‑opportunity employer that is committed to diversity and inclusion. We prohibit discrimination and harassment on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws.

The pay range for this role is $154,280 to $181,500.

We provide training and require maintenance of trained status and compliance with all relevant aspects of the PROCEPT Bio Robotics Quality Management System and EHS policies to ensure product and regulatory compliance.