Manufacturing Engineer 2, NPI Transfer

Overview --------

The New Product Introduction (NPI) Engineer 2 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.
• 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.

Requirements ------------

• Bachelors degree in Engineering, or Engineering Technology
• 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
• 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

Qualifications and Restrictions -----------------------------

• Bachelors 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
• Preferred knowledge of 3D Modeling software (Creo, Solid Works, etc)

Note: 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.