Reliability Quality Engineer

Procept Biorobotics-posted about 1 month ago
$100,000 - $118,000/Yr
Full-time • Mid Level
San Jose, CA
501-1,000 employees
Miscellaneous Manufacturing
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Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities. As PROCEPT BioRobotics continues to expand, the Design Quality Assurance group is seeking a Reliability Quality Engineer to support ongoing reliability initiatives. The Reliability Quality Engineer will collaborate with product development and sustaining teams to ensure that PROCEPT BioRobotics delivers highly reliable products through the application of reliability tools such as Weibull Analysis, Failure Mode Effects & Criticality Analysis (FMECA), Fault Tree Analysis (FTA), structured problem-solving, reliability modeling, reliability predictions, and reliability testing.

  • Define and execute reliability testing protocols for mechanical, electrical, environmental, and software-related systems.
  • Support Design Control activities, risk management files, verification and validation protocols, and design reviews.
  • Collaborate with cross-functional teams (R&D, Manufacturing, Supplier Quality, Regulatory, and Failure Analysis) to ensure product quality, reliability, and compliance.
  • Monitor field reliability metrics, complaint data, and nonconformance trends.
  • Understand and adhere to the PROCEPT BioRobotics EHS policy.
  • Evaluate and demonstrate the reliability of mechanical, electrical, and electronic components within complex medical robotic systems.
  • Perform reliability prediction analyses using established industry standards such as MIL-HDBK-217, Telcordia, and FIDES.
  • Apply knowledge of ISO 13485 and 21 CFR Part 820, and remain familiar with other applicable international standards.
  • Define reliability requirements and develop new test specifications, methodologies, and coverage strategies to ensure the reliability of both current and next-generation products.
  • Plan and conduct Accelerated Life Testing (ALT) and Highly Accelerated Life Testing (HALT) to assess product design robustness.
  • Design and build custom test fixtures and automated setups for reliability testing at the system, subsystem, and component levels.
  • Maintain automated testing frameworks using Python and C++ for test execution and data analysis.
  • Demonstrate strong attention to detail, excellent organization, and effective communication skills, with flexibility and adaptability to take on new tasks.
  • Bachelor's degree with 2 years of relevant experience, or Master's degree with 1 year of relevant experience in Mechanical, Biomedical, or Electrical/Electronic Engineering.
  • Ability to learn and apply statistical processes and techniques such as prediction and Weibull analysis.
  • Strong written and verbal communication skills.
  • ASQ CQE or CRE certification preferred.
  • Basic machine tool and manufacturing experience is a plus.
  • Experience with medical device testing or product development is a plus.
  • PROCEPT's health and wellness benefits for employees are second to none in the industry.
  • We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 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, and many more!
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