Job Description
Job Description
Summary
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.
Key Responsibilities
- 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
Qualifications
- 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
Additional Information
- No direct supervisory responsibility; provides technical guidance and support
- Travel required (approximately 20%, domestic and international)
Company DescriptionLabor Solutions, LLC is a leader in the professional, temporary, and direct hire industry throughout the Midwest area. Our clients range from individual entrepreneurs to large corporations, and while we are big enough to serve Fortune 100 companies, we are small enough to stay nimble in an always-changing market.
Thank you!
Company Description
Labor Solutions, LLC is a leader in the professional, temporary, and direct hire industry throughout the Midwest area. Our clients range from individual entrepreneurs to large corporations, and while we are big enough to serve Fortune 100 companies, we are small enough to stay nimble in an always-changing market.\r\n\r\nThank you!