Senior Manufacturing Engineer (Laser Welding)

PROCEPT BioRobotics•Headquarters, KY

18d•$131,060 - $154,190

About The Position

Embark on an exciting journey that will revolutionize the way men suffering from BPH are treated. Join us as a Senior Manufacturing Engineer and be at the forefront of engineering technologies for the groundbreaking Aquabeam Robotic System. Your mission? To establish engineering technologies for the operations team to become best in class manufacturers of medical devices and equipment. This isn't just any job - it's a chance to make a real difference. We need someone driven, motivated, and determined to drive new process technologies. Get ready to transform lives and shape the future of healthcare!

Requirements

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, 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 ISO9001and EN46001.
Basic working knowledge of CAD (Solidworks or other) software.

Nice To Haves

Recognized as subject matter expert in process technologies such as laser cutting, welding, brazing, and joining.
Experience supporting medical device manufacturing.
Experience in 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 proficient in SolidWorks.

Responsibilities

Lead engineering support to manufacturing and resolve issues related to process and equipment (e.g. troubleshoot existing manufacturing processes, fixtures, tooling or equipment)
Develop training programs for operators and engineers
Responsible for helping define 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.
Responsible for process documentation and ensuring it is kept current like Manufacturing Instructions, Standard works documents, PFMEA, standard works and Control Plans
Work with R&D and Process Development teams to develop weld schedule development for transfer of new products into commercial manufacturing, both in-house and at contract manufacturer
Identify, define and execute new technical projects that improve manufacturing processes – this will include 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