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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.