Manufacturing Engineer - NPI

Norman Noble, Inc.; Cleveland (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Norman Noble, Inc. in Cleveland, OH, seeks a Manufacturing Engineer to lead end-to-end NPI process development and production transfer for innovative medical devices.

You will own process flows, work instructions, tooling, and equipment, while aligning design with manufacturing to scale production and ensure quality. The role requires hands-on engineering in NPI, process validation, Lean, GD&T, and SolidWorks; on-site work with cross-functional teams; strong communication and problem-solving

Qualifications

• Hands-on engineering experience in an NPI role in medical device manufacturing.
• Process validation, Lean and project management experience.
• Experience with machining processes and the manufacture of small metallic parts (CNC, laser cutting, electropolishing).
• Bachelor’s degree in an Engineering discipline (biomedical, chemical, materials, or mechanical).
• Experience with fixture design and fabrication is strongly preferred.
• Working knowledge of ISO 9001:13485 preferred and ability to interpret GD&T drawings.
• Experience with SolidWorks, MiniTab, MS Office, Teams and similar business tools.
• Excellent communicator with ability to lead cross-functional teams and explain technical concepts clearly.

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 quality standards.
• Document program results and ensure compliance with internal and external requirements, including deviations.
• Work with manufacturing staff, engineers, customers, vendors, and suppliers.
• Develop production work instructions and process documentation that translate design intent into repeatable manufacturing execution.
• Define and lead operator training strategy for new products, including training materials and hands-on support.
• 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

NPI manufacturing

Lean

Process validation

CNC machining

Laser cutting

Electropolishing

GD&T

SolidWorks

MiniTab

MS Office

Team leadership

Communication

Problem solving

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.