NPI Manufacturing Engineer I — Medical Devices

Cook Medical; Bloomington (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Cook Medical in Bloomington, IN seeks a Manufacturing Engineer 1 for New Product Introduction. You will design and optimize processes to manufacture new medical devices, bridging Product Development to Manufacturing, Quality and Operations.

You will lead design-for-manufacturing activities, develop validations, and document PFMEAs, Instructions, and drawings, collaborating with R&D, operations and production engineering to transfer projects to manufacturing.

Qualifications

• Bachelor’s degree in Engineering or Engineering Technology.
• Experience in Class II/III medical device manufacturing and process validation.
• Knowledge of ISO13485/FDA GMP and related standards.
• Strong analytical and problem-solving abilities.
• Proficiency with Microsoft Office (Word, Excel, Visio, PowerPoint, MS Project).
• Prefer Creo or SolidWorks for 3D modeling.
• Experience with design for manufacturing and lean principles.

Responsibilities

• Collaborate on design, development, and implementation of new manufacturing processes.
• Perform design for manufacturing, process validation, and process capability work.
• Apply risk-based approaches during development, validation, and transfer to manufacturing.
• Maintain process documentation (PFMEA, production instructions, drawings).
• Coordinate with R&D, Operations, and Production engineering for transfer to manufacturing.
• Evaluate in-house vs supplier options to optimize costs.
• Define and procure new equipment for manufacturing processes.
• Ensure projects meet timelines and performance expectations.
• Communicate effectively across levels of the organization.
• Support line start-up and training; promote integrated manufacturing and quality at source.

Skills

Process validation & DFM

Lean manufacturing

Analytical problem solving

Communication skills (oral/written/ppt

Microsoft Office Suite

3D modeling software

Education

Bachelor’s degree in Engineering or Engineering Technology

Tools

Creo

SolidWorks

MS Project

Excel

Visio

PowerPoint

Job description

Cook Medical in Bloomington, IN seeks a Manufacturing Engineer 1 for New Product Introduction. You will design and optimize processes to manufacture new medical devices, bridging Product Development to Manufacturing, Quality and Operations.

You will lead design-for-manufacturing activities, develop validations, and document PFMEAs, Instructions, and drawings, collaborating with R&D, operations and production engineering to transfer projects to manufacturing.