PROCEPT BioRobotics · 1 hour ago
Quality Engineer, Sustaining
San Jose, CA
Full-time
Onsite
Entry Level
$100K/yr - $118K/yr
1+ years expPROCEPT BioRobotics is dedicated to revolutionizing treatment for benign prostatic hyperplasia through innovative surgical robotics. The Quality Engineer, Sustaining will support manufacturing operations by ensuring compliance with quality regulations and assist in continuous improvement initiatives within the Quality Engineering team.
Health CareManufacturingMedical DeviceRobotics
No H1B
U.S. Citizen Only
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
Qualification
Required
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)
Preferred
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
Benefits
Full medical coverage
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
Annual performance bonus
Equity
Company
PROCEPT BioRobotics
PROCEPT BioRobotics is a surgical robotics company that develops water-based robotic systems for prostate surgery.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$820.34MKey Investors
CIBC Innovation BankingFidelityViking Global Investors
2024-10-29Post Ipo Secondary· $175M
2023-08-01Post Ipo Equity· $150M
2022-10-10Post Ipo Debt· $52M
Leadership Team
Mohan F. Sancheti
Vice President Operations
Recent News
thefly.com
2025-12-09
2025-11-07
PROCEPT BioRobotics
2025-11-05
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