Manufacturing Engineer , NPI Transfer
Listed on 2026-02-24
-
Engineering
Manufacturing Engineer, Quality Engineering
Manufacturing Engineer 1, NPI Transfer (Finance)
Requisition
Posting Date 23 hours ago (2/16/2026 7:31 PM)
Job Location(s):
Bloomington, IN, United States
Travel:
None
Position Type:
Full Time
Company:
Cook Inc - Bloomington
Category:
Engineering
The New Product Introduction (NPI) Engineer will bridge Product Development into Manufacturing Engineering, Quality, and Operations. They will be responsible for configuring and optimizing of processes required to manufacture new medical devices. Additionally, identify and evaluate innovative processing options based on product attributes, including evaluation for Design for Manufacturability (DFM) and Value Engineering.
Responsibilities- Collaborate in a team of engineers focused on design, development, and implementation of new processes (within Cook Inc facilities) required for the manufacture of new device designs.
- Execute methods needed for compliant, efficient, and effective process development (design for manufacturing, process validation, process capability, lean manufacturing, equipment selection and specification development).
- Utilize and apply a risk based approach during the development, implementation, and validation of all processes.
- Responsible for process documentation (PFMEA's, Production Instructions, Drawings, etc.) associated with new products.
- Collaborate with R&D team, Operations, and Production engineering to ensure the effective completion of all activities associated with transfer to manufacturing of an R&D Engineering project / objective.
- Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and Cook's Quality Management System where applicable.
- Advise new product development team on make vs. buy decisions for components.
- Define, identify, and procure new equipment for manufacturing processes.
- Complete projects within specific time lines and meet performance expectations.
- Work and interact effectively and professionally with others throughout various levels of the global organization.
- Have effective oral, written, and presentation communication skills.
- Work in collaborative and independent work situations and environments with minimal supervision.
- Represent Operations Principles of the Cook Operating System.
- Champion line start up, support, and training.
- Promote and drive integrated manufacturing, driving quality at source.
- Strictly adhere to safety requirements.
- Bachelor's degree in Engineering.
- Preferred knowledge of process validation, design for manufacturing, statistics and lean manufacturing principles.
- Preferred knowledge of medical device quality standards ISO
13485/FDA practices, GMP and similar regulated industry standards. - Preferred knowledge of 3D Modeling software (Creo, Solid Works, etc).
- Works under general office environmental conditions.
- Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
- Frequently required to sit, stand, walk, and communicate.
Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) of this employment position.
"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."
Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.
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