New Product Introduction Engineer 1

The New Product Introduction (NPI) Engineer 1 will bridge Product Development into Manufacturing Engineering, Quality, and Operations. They will be responsible for configuring and optimizing 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.

- 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 (PFMEAs, 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 the transfer to manufacturing of an R&D Engineering project/objective.

- Advise the new product development team on making vs. buying decisions for components.
- Define, identify, and procure new equipment for manufacturing processes.
- Ability to complete projects within specific time lines and meet performance expectations.
-Must work and interact effectively and professionally with and for others throughout various levels of the global organization
- Maintain regular and punctual attendance
- Must have effective oral, written and presentation communication skills
- Ability to 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.

- Bachelor's degree in Engineering, or Engineering Technology
- Experience working in a Class II/III medical device manufacturing environment, 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 Software (ie, Word, Excel, Visio, PowerPoint, MS Project)
- Preferred knowledge of 3D Modeling software (Creo, Solid Works, etc.)

Physical Requirements:

- Works under general office environmental conditions.
- Sitting for extended periods, utilizing close visual acuity for working with computers, equipment, etc.
- Frequently required to sit, stand, walk, and communicate

- Must be able to perform the essential functions of the job, with or without reasonable accommodations.
-Ability to travel overnight up to 10% of the time, if needed.

**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) for this employment position.