Overview

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.

- Advice 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 meeting 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 driven integrated manufacturing, driving quality at source.

Qualifications

- Bachelor's degree in Engineering- Minimum of 3 years experience working in Class II/III medical device manufacturing environment with qualification of new processes and equipment validation- 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, Power point, MS Project)- Preferred knowledge of 3D Modeling software (Creo, Solid Works, etc)

Physical Requirements:

- 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

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