Quality Engineer, Sustaining at PROCEPT BioRobotics

San Jose, California, United States

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Surgical Robotics, HealthcareIndustries

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)
Preferred Skills
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

Skills

FDA 21 CFR Part 820

ISO 13485

ISO 14971

EU MDR

Quality System Regulation

line clearance

in-process inspections

final release

manufacturing compliance

Quality Operations

PROCEPT BioRobotics

Develops robotic solutions for BPH treatment

About PROCEPT BioRobotics

PROCEPT BioRobotics develops robotic solutions specifically for treating benign prostatic hyperplasia (BPH), a condition that affects many older men by causing prostate enlargement and urinary issues. Their main product, the AquaBeam Robotic System, utilizes Aquablation therapy, which combines real-time imaging, robotics, and waterjet technology to precisely remove prostate tissue in a minimally invasive manner. This system is designed for urologists and healthcare facilities, focusing on enhancing patient outcomes and making surgical procedures more efficient. Unlike competitors, PROCEPT BioRobotics emphasizes predictable results and reduced complications, which has led to their technology being recognized in clinical guidelines. The company's goal is to improve the quality of life for patients suffering from BPH through advanced surgical solutions.

Redwood City, CaliforniaHeadquarters

2009Year Founded

$319.1MTotal Funding

IPOCompany Stage

Robotics & Automation, HealthcareIndustries

501-1,000Employees

Benefits

Health Insurance

401(k) Company Match

401(k) Retirement Plan

Paid Vacation

Paid Parental Leave

Paid Holidays

Wellness Program

Gym Membership

Risks

Competition from Intuitive Surgical and Medtronic may impact market share.

$175 million public stock offering could lead to shareholder dilution.

Reliance on AquaBeam System makes company vulnerable to technological failures.

Differentiation

AquaBeam Robotic System offers image-guided, minimally invasive urologic surgery.

Aquablation therapy provides effective outcomes regardless of prostate size or surgeon experience.

PROCEPT has over 100 peer-reviewed publications supporting Aquablation therapy's benefits.

Upsides

Increasing adoption of robotic-assisted surgeries boosts demand for AquaBeam System.

Global urology devices market projected to grow at 6.9% CAGR until 2030.

FDA's supportive regulatory environment favors innovative medical technologies like PROCEPT's.

Land your dream remote job 3x faster with AI

Try Jobo Free