Manufacturing Engineer - NPI

Norman Noble•Cleveland, OH

4d•Onsite

About The Position

Norman Noble is a renowned, privately-held contract manufacturer of life sustaining medical devices that help to improve or save lives. Our reputation for excellence and our outstanding team have been providing service to our customers for 80 years. Our state-of-the-art facilities support innovative solutions where we manufacture, finish and inspect medical device implants for customers worldwide.

Requirements

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).
Experience with Solidworks, MiniTab, MS Office, Teams and similar business tools required.
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
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

Nice To Haves

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
Must have ability to interpret engineering drawings and have understanding of GD&T.

Responsibilities

Lead end-to-end manufacturing process development and production transfer for new products.
Own NPI manufacturing deliverables including process flows, work instructions, tooling, and equipment.
Create and define new manufacturing processes and assembly methods for complex or novel products.
Align product design with manufacturing processes and customer requirements to scale production while meeting exacting quality standards.
Document program results and ensure compliance with internal and external requirements, including deviations.
Works with manufacturing/production staff, engineers, customers, vendors, and suppliers.
Develop production work instructions, process documentation, and visual aids that translate design intent into repeatable, compliant manufacturing execution.
Define and lead operator training strategy for new products, including development of training materials, hands-on training support, and verification of operator readiness during pilot builds and production ramp.
Act as a manufacturing subject matter expert for NPI programs and influence cross-functional decisions.
Support other Manufacturing Engineer team members.
Balance quality, cost, delivery, and risk in manufacturing decisions.
Align technical solutions with overall business strategy and priorities.