NPI Manufacturing Engineer I – Medical Devices

Cook Inc - Bloomington; Bloomington (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Cook Inc - Bloomington in Bloomington, IN is seeking a Manufacturing Engineer 1 for New Product Introduction (NPI). The role focuses on designing and optimizing manufacturing processes for new medical devices, bridging Product Development with Manufacturing Engineering, Quality and Operations.

Responsibilities include process development, validation, documentation, and collaboration with R&D and Operations to transfer designs into manufacturing, while evaluating make vs buy options and equipment

Qualifications

• Bachelor's degree in Engineering or Engineering Technology
• Experience in Class II/III medical device manufacturing with qualification of new processes and equipment validation preferred
• Knowledge of process validation, design for manufacturing, statistics and lean manufacturing principles
• Knowledge of medical device quality standards ISO13485/FDA practices, GMP and similar regulated industry standards
• Experience using analytic skills and problem solving
• Working knowledge of Microsoft Office (Word, Excel, Visio, PowerPoint, MS Project)
• Preferred knowledge of 3D modeling software (Creo, SolidWorks, etc)

Responsibilities

• Collaborate in a team of engineers focused on design, development, and implementation of new manufacturing processes for new device designs.
• Execute methods for compliant, efficient process development (design for manufacturing, process validation, process capability, lean manufacturing, equipment selection).
• Apply a risk-based approach during development, implementation and validation of all processes.
• Maintain documentation (PFMEA, Production Instructions, Drawings) for new products.
• Coordinate with R&D, Operations, and Production engineering to transfer from R&D to manufacturing.
• Evaluate in-house vs supplier options and costs.
• Define and procure equipment for manufacturing processes.

Tools

Creo

SolidWorks

Job description

Cook Inc - Bloomington in Bloomington, IN is seeking a Manufacturing Engineer 1 for New Product Introduction (NPI). The role focuses on designing and optimizing manufacturing processes for new medical devices, bridging Product Development with Manufacturing Engineering, Quality and Operations.

Responsibilities include process development, validation, documentation, and collaboration with R&D and Operations to transfer designs into manufacturing, while evaluating make vs buy options and equipment