Manufacturing Engineer 2 - NPI

• ◆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.

• ✓Bachelor's degree in Engineering, or Engineering Technology- Minimum of 2+ 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

• ✓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.