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PROCEPT BioRobotics · 5 hours ago

Reliability Quality Engineer

San Jose, CA

Full-time

Onsite

Entry, Mid Level

$100K/yr - $118K/yr

1+ years exp

PROCEPT BioRobotics is dedicated to revolutionizing treatment for benign prostatic hyperplasia through innovation in surgical robotics. The Reliability Quality Engineer will support ongoing reliability initiatives by collaborating with product development teams and applying various reliability tools to ensure high-quality products.

Health CareManufacturingMedical DeviceRobotics

No H1B

U.S. Citizen Only

Responsibilities

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

Qualification

Reliability EngineeringWeibull AnalysisFMECAReliability TestingISO 13485MIL-HDBK-217PythonC++ASQ CQECommunication SkillsAttention to Detail

Required

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

Preferred

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