NPI Manufacturing Engineer - Medical Devices

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, 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