Manufacturing Engineer

Manufacturing Engineer (Assembly Process)

On-site position.

Join a growing medical device manufacturer supporting low-volume, high-mix electromechanical products. This role focuses on developing, scaling, and optimizing assembly processes while driving continuous improvement, validation activities, and manufacturing excellence in a regulated environment.

• Design and optimize assembly processes, tooling, fixtures, and production line layouts.
• Support new product introductions, design transfers, and manufacturing scale-up efforts.
• Develop work instructions, process documentation, BOM structures, and quality controls.
• Lead process validation activities including IQ/OQ/PQ.
• Drive CAPA investigations, root cause analysis, and corrective actions.
• Collaborate cross-functionally with engineering, quality, production, and customers.
• Train and mentor manufacturing personnel on assembly processes and GMP compliance.
• Identify opportunities to improve efficiency, throughput, quality, and cost.

• Manufacturing, Mechanical, Biomedical, or Industrial Engineering degree (or equivalent experience).
• Experience supporting electromechanical assemblies in a production environment.
• Hands-on experience with tooling, fixtures, process development, and assembly operations.
• CAD proficiency (Solid Works, Creo/ProE, AutoCAD, or similar).
• Knowledge of root cause methodologies such as DMAIC, 5 Whys, and Fishbone.
• Familiarity with ISO 9001, ISO 13485, GMPs, and regulated manufacturing environments.
• Medical device experience preferred.

• Medical device manufacturing environment.
• High visibility, hands-on engineering role.
• New product introduction and process development focus.
• Significant cross-functional collaboration.
• Opportunity to impact manufacturing scalability and quality systems/