Manufacturing Engineer - NPI

Norman-Noble; Cleveland (OH); On-site; USD 90,000 - 125,000; Full time

Job summary

Norman Noble, Inc. is a leading contract manufacturer of life-sustaining medical devices with a long history of excellence.

We seek a Manufacturing Engineer to lead end-to-end process development and NPI transfers for new products, aligning design with production needs and quality standards. This on-site role collaborates with cross-functional teams and suppliers to drive scalable, compliant manufacturing solutions.

Qualifications

• Hands-on engineering experience in an NPI role in medical, aerospace, or automotive manufacturing.
• Experience with fixture design and interpretation of GD&T.
• Bachelor’s degree in an Engineering discipline.
• Knowledge of ISO 9001:13485 preferred.

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.
• Develop production work instructions and process documentation.
• Balance quality, cost, delivery, and risk in manufacturing decisions.

Skills

NPI experience

Lean and project management

GD&T understanding

ISO 9001:13485 knowledge

SolidWorks

Education

Bachelor's degree in Engineering

Tools

SolidWorks

MiniTab

MS Office

Teams

Job description

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.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.