Manufacturing Engineer - NPI
On-siteCleveland, Ohio, United States
Job Summary
Lead end-to-end manufacturing process development and production transfer for new products, owning deliverables including process flows, work instructions, tooling, and equipment. Create new manufacturing processes and assembly methods for complex products while aligning design with customer requirements to scale production. Document program results, ensure compliance with internal and external standards, and develop production work instructions that translate design intent into repeatable execution. Define operator training strategies, including materials and hands-on support, to verify readiness during pilot builds and ramp. Act as a manufacturing subject matter expert, influencing cross-functional decisions and balancing quality, cost, delivery, and risk. Support team members and balance multiple projects in a fast-paced environment.
Required Qualifications
- Hands-on engineering experience in comparable NPI role in medical, aerospace, or automotive manufacturing
- Demonstrated expertise in process validation, Lean and project management
- Bachelor's degree in an Engineering discipline required (biomedical, chemical, materials, or mechanical)
- Must have ability to interpret engineering drawings and have understanding of GD&T
- Experience with Solidworks, MiniTab, MS Office, Teams and similar business tools required
- Mechanical aptitude with strong analytical, problem-solving and trouble-shooting abilities essential
- Must be able to work effectively in fast-paced environment, managing multiple projects to successfully meet deadlines
- Must be self-motivated and demonstrate initiative and drive to organize and manage projects to successful outcomes
- Position is on-site/in office
Desired Qualifications
- Experience with machining processes and the manufacturing of small metallic parts is preferred. These may include: CNC machining, laser cutting, and/or electropolishing
- Experience with fixture design and fabrication is strongly preferred
- Working knowledge of ISO 9001:13485 preferred
- Excellent communicator (written and verbal), with the ability to lead cross-functional teams through process development and product. Must be able to explain technical concepts in non-technical terms to staff
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