Manufacturing Engineer

The Manufacturing Engineer is responsible for developing, supporting, and continuously improving manufacturing processes, equipment, and tooling used in the production of high-precision medical device components. This role supports complex manufacturing operations—including braiding, extrusion, secondary operations, and precision assembly—within a regulated environment.

The Manufacturing Engineer partners closely with Manufacturing, Quality, Design Engineering, Supply Chain, and leadership to ensure processes are safe, efficient, compliant, and scalable. This role applies data-driven problem solving, sound engineering principles, and Lean/continuous improvement methodologies while maintaining compliance with FDA QSR (21 CFR Part 820), ISO 13485
, and internal standards.

• Analyze production data (yield, scrap, volumes, performance) to optimize manufacturing processes
• Design, develop, and implement manufacturing processes, tooling, fixtures, and work instructions
• Support and improve complex manufacturing processes including braiding, extrusion, and precision assembly
• Troubleshoot manufacturing, process, and equipment issues to improve quality, delivery, and cost
• Plan workflow, equipment placement, and space utilization to improve efficiency and material flow
• Collaborate cross-functionally to develop and maintain SOPs, work instructions, and manufacturing documentation
• Support cost analysis, capacity planning, and standard cost reviews
• Identify waste and process variation; implement Lean, Six Sigma, and continuous improvement initiatives
• Support process validation activities (IQ/OQ/PQ), change control, and CAPA/root cause investigations
• Evaluate and recommend tooling, equipment, automation, and process improvements
• Assist with training manufacturing personnel on new or revised processes
• Read and interpret technical drawings, specifications, blueprints, and diagrams

• Bachelor’s degree in manufacturing, Mechanical, Biomedical Engineering, or related field
• 5+ years of Manufacturing Engineering experience in a regulated industry (medical device preferred)
• Experience supporting complex component manufacturing (braiding, extrusion, or precision assembly preferred)
• Working knowledge of FDA QSR and ISO 13485
• Experience with Lean manufacturing and continuous improvement methodologies
• Strong analytical, problem-solving, and communication skills
• Proficiency with Microsoft Office; exposure to ERP/MRP systems

• No direct supervisory responsibility; provides technical guidance and support
• Travel required (approximately 20%, domestic and international)