Manufacturing Engineer - NPI

Please note; this role is based in Cleveland!

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.

Duties and 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.

Skills and Experience

• Hands-on engineering experience in comparable NPI role in medical, aerospace, or automotive manufacturing
• Demonstrated expertise in process validation, Lean and project management.
• Experience with machining processes and the manufacturing of small metallic parts is preferred. These may include: CNC machining, laser cutting, and/or electropolishing.
• Bachelor’s degree in an Engineering discipline required (biomedical, chemical, materials, or mechanical).
• 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.
• 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
• Position is on-site/in office.

Norman Noble, Inc. is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of age, gender, gender identity or expression, sexual orientation, marital status, race, color, ethnicity, religion or creed, national origin, citizenship, disability, veteran status, political affiliation, or any protected characteristics as required by federal, state, or local law. We are committed to the inclusion of qualified individuals, including those with disabilities who require reasonable accommodation to perform essential job functions.

We are an equal opportunity employer. All applicants receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Norman Noble is a world leader in micro precision manufacturing. As a contract manufacturer of medical device implants and aerospace parts, Norman Noble specializes in micromachining of exotic materials to very complex geometries with dimensional tolerances to /-.0001". For 75 years, customers have relied on our expertise, capabilities, and professionalism. Applying incomparable knowledge and experience, our highly trained staff of engineers, technicians, and machinists develop and execute custom manufacturing processes required to take a project from prototype to full-scale manufacturing.