Quality Engineer, Sustaining

Procept Biorobotics•San Jose, CA

48d•$100,000 - $118,000

About The Position

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. Do you want to be part of an innovative, cutting edge technology, robotics company that is changing how BPH is treated? Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learn from one another? Are you a leader who wants to make a difference and improve processes? Are you detailed-oriented? At PROCEPT BioRobotics you will have an opportunity to contribute and greatly support our continuous improvement philosophy by being part of our Quality Engineering team. This position has a unique impact on the quality and reliability of our devices. You will work with cross-functional teams to maintain and improve the Quality System within the requirements of FDA's Quality System Regulation (QSR), ISO 13485 (ISO) and EU MDR. Being detail and solution oriented, proactive, and self-managed will assist in the success of this position.

Requirements

Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, or related field), Life Sciences, or equivalent experience.
1-3 years of experience in quality, manufacturing, or engineering in a regulated environment (medical device preferred).
Familiarity with ISO 13485 and FDA 21 CFR Part 820 requirements.
Basic understanding of root cause analysis tools (e.g., 5-Why, fishbone) and nonconformance investigations.
Ability to read and interpret engineering drawings and use basic metrology tools (calipers, micrometers).

Nice To Haves

Experience in medical device manufacturing (Class II or III devices).
Knowledge of process validation (IQ, OQ, PQ) and statistical tools (SPC, Gage R&R, AQL).
Experience with MES or eDHR systems.
Exposure to cleanroom operations and environmental monitoring.

Responsibilities

Support manufacturing operations by ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
Perform line clearance, in-process inspections, and final release activities under guidance from senior engineers.
Assist with nonconformance investigations (NCMRs), including data collection, basic root cause analysis, and documentation.
Support cleanroom controls and environmental monitoring activities to maintain compliance with Class 8 cleanroom requirements.
Assist with execution of process validations (IQ, OQ,PQ) and data analysis for validation and qualification activities.
Participate in risk management activities (e.g.,pFMEA updates, control plan reviews) under the direction of senior engineers.
Identify and communicate potential quality issues or process improvements to reduce defects and improve yield.
Support cross-functional teams in resolving day-to-day quality and production challenges.
Maintain accurate and complete quality documentation, including inspection records, work instructions, and quality procedures.
Support internal and external audits (FDA, ISO, MDSAP) by preparing records and assisting with audit responses.
Assist with new product introduction (NPI) activities by supporting design transfer and process validation requirements.