Senior NPI Manufacturing Engineer at PROCEPT BioRobotics

San Jose, California, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, RoboticsIndustries

Requirements

Bachelor’s degree in engineering (Mechanical, Electrical, or related)
Experience in developing and transferring manufacturing processes for new product introductions, product changes, and enhancements
Experience interfacing with R&D to develop and transfer new products, designs, and processes into production
Strong skills in Design for Excellence, including Design for Manufacturing (DFM), Design for Assembly (DFA), Design for Reliability (DFR), and Design for Serviceability (DFS)
Project management skills, including schedule creation/management, cross-functional collaboration, conflict resolution, and driving design transfer deliverables
Ability to create process validation protocols, conduct process optimization studies, verifications, and validations, and generate reports
Proficiency in owning and maintaining process documentation (e.g., Manufacturing Instructions, Standard Work, PFMEAs, Control Plans)
Experience leading design transfer efforts, including process validation (IQ, OQ, PQ), equipment qualification, and documentation
Ability to generate custom fixture CAD models and detailed drawings, and complete/coordinate fixture fabrication, testing, and qualification
Experience collaborating to develop process CTQ (Critical to Quality) indicators
Ability to train, develop, and provide work direction to operators and technicians
Maintain trained status and comply with PROCEPT BioRobotics Quality Management System, Quality, and EHS policies for regulatory compliance
Willingness to travel up to 10% (domestic and international)

Responsibilities

Collaborate with R&D during early product design to influence architecture and ensure manufacturability, serviceability, and process repeatability
Provide DFM, DFA, DFR, and DFS recommendations, ensuring implementation during new component and assembly design concept and detailed drawing reviews
Represent operations team's perspective for new product activities from product development to production release
Create process validation protocols, conduct process optimization studies, verifications, and validations, and generate verification and validation reports
Own and maintain up-to-date process documentation, including Manufacturing Instructions, Standard Work, PFMEAs, and Control Plans for new product design projects
Lead design transfer efforts, including process validation (IQ, OQ, PQ), equipment qualification, and documentation (e.g., manufacturing instructions, control plans, PFMEAs)
Collaborate with team to develop process CTQ (Critical to Quality) indicators
Generate custom fixture CAD models and detailed drawings; complete or coordinate fixture fabrication, testing, and qualification
Drive projects as an NPI leader through schedule creation/management, cross-functional collaboration, conflict resolution, and design transfer deliverables completion
Communicate project status and actions to internal partners
Train, develop, and/or provide work direction to operators and technicians
Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance
Understand and adhere to PROCEPT BioRobotics’ Quality and EHS policies

Skills

NPI

Manufacturing Processes

Design for Manufacturability

Process Transfer

Project Management

R&D Collaboration

Design for Excellence

DFM

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