Senior Manufacturing Engineer (Laser Welding)

PROCEPT BioRobotics Corporation; Headquarters (ID); On-site; USD 85,000 - 110,000; Full time

Job summary

PROCEPT BioRobotics Corporation is seeking a Senior Manufacturing Engineer to lead engineering support for manufacturing processes related to medical devices. You will help establish engineering technologies aimed at making operations best-in-class.

The role requires a BS in engineering and a minimum of 5 years experience, along with expertise in root cause analysis and familiarity with FDA and ISO standards. This position involves significant collaboration across teams as well as travel opportunities.

Qualifications

• Minimum 5 years experience if BS in engineering or minimum 3 years with MS.
• Experience with ISO9000, FDA QSR regulatory processes.
• Knowledge of design control and cGMP requirements for medical devices.

Responsibilities

• Lead engineering support to manufacturing and resolve issues.
• Develop training programs for operators and engineers.
• Champion continuous improvement and identify projects for lean systems.
• Design and evaluate new fixtures and equipment.

Skills

Root cause analysis

Problem solving

Lean manufacturing

Six Sigma tools

Education

BS in engineering discipline

MS in engineering (preferred)

Tools

CAD software (SolidWorks)

Microsoft Office

Job description

Job Overview

Senior Manufacturing Engineer – Aquabeam Robotic System. Your mission is to establish engineering technologies for the operations team to become best‑in‑class manufacturers of medical devices and equipment.

Responsibilities

• Lead engineering support to manufacturing and resolve issues related to process and equipment (troubleshoot existing manufacturing processes, fixtures, tooling or equipment).
• Develop training programs for operators and engineers.
• Help define the technology and equipment roadmap for medical device technologies.
• Champion continuous improvement by identifying projects to create and support best‑in‑class lean manufacturing systems to maximize yield, capacity, and capability.
• Identify, justify and implement multiple significant Design for Manufacturability (DFM) projects to reduce manufacturing costs, improve processes, increase product reliability, and enhance process capability.
• Design and evaluate new and existing fixtures and equipment, test methods, specifications, layouts, and standards.
• Maintain process documentation, including Manufacturing Instructions, Standard Works documents, PFMEA, Standard Works and Control Plans.
• Work with R&D and Process Development teams to develop welding schedules for transfer of new products into commercial manufacturing, both in‑house and at contract manufacturers.
• Identify, define, and execute new technical projects that improve manufacturing processes – including developing the scale, scope and ROI.
• Design, build or procure improved fixtures, tooling or equipment to increase quality, reliability, capacity, and yield.
• Provide engineering support to outside suppliers and contract manufacturers, ensuring quality and production targets are met.
• Train, develop, and/or provide work direction to operators and technicians.
• May require up to 20% travel, domestic and international.

Required Qualifications

• BS in an engineering discipline such as welding, mechanical or electrical engineering with a minimum of 5 years’ experience or an MS in engineering with a minimum of 3 years’ experience.
• Extensive experience with root cause analysis and problem solving for both technical and process issues.
• Experience working in a structured design process such as ISO9000 or FDA QSR, and knowledge of regulatory approval process and requirements.
• Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485‑2003 or ISO9001 and EN46001.
• Basic working knowledge of CAD (SolidWorks or other) software.

Preferred Qualifications

• Recognized as a subject matter expert in process technologies such as laser cutting, welding, brazing, and joining.
• Experience supporting medical device manufacturing.
• Experience leading highly technical projects in a cross‑functional environment both internally and with CMOs/Vendors.
• Preferred experience with Lean and Six Sigma tools.
• Excellent computer skills with specific skills in Microsoft Office and proficiency in SolidWorks.