Research and Development Engineer , Process Development

Overview

The Process Development Engineer is responsible for designing and optimizing processes and test methods required to manufacture new medical devices. Identify and evaluate innovative processing options based on product attributes for products, including evaluation based on technical and economic feasibility. Execute cost-effective systems to enhance the speed and quality of processing, and ensure produced items comply with government regulations and industry standards.

• Collaborate in a team of engineers focused on design, development, and implementation of new processes and test methods required for the development and manufacture of new device designs, within Cook Medical facilities and/or with third party suppliers.
• Execute methods needed for efficient and effective process and test method development (design for manufacturing/assembly, process validation, process capability, lean manufacturing, equipment selection and qualification, and specification development).
• Ensure that a risk-based approach is applied during the development, implementation, and validation of all processes and test methods.
• Responsible for process documentation (PFMEAs, Validation Plans, Production Instructions, Drawings, etc.) associated with new production processes.
• Liaise with the new product introduction team and production engineering for process engineering layout plans and implementation in relation to new processes and production lines.
• Collaborate with R&D, Operations, and Manufacturing Engineering to ensure the effective completion of all activities associated with transfer to manufacturing of an R&D engineering project/objective.
• Compare costs and benefits when determining manufacture of product in-house or supplier selection.
• Define, identify, procure, and qualify new equipment for manufacturing processes and test methods.
• Complete projects within specific timelines and costs, and meet performance expectations.
• Work effectively and professionally with and for others across various levels of the global organization.
• Maintain regular and punctual attendance and demonstrate strong communication skills (oral, written, and presentation).
• Ability to work in collaborative and independent work situations with minimal supervision.

• Minimum Bachelor's degree in Engineering or Engineering Technology.
• Preferred minimum 3 years experience in a Class II/III medical device manufacturing environment.
• Strong knowledge of process validation, design for manufacturing, statistics, Design of Experiments (DOE), and lean manufacturing principles.
• Strong knowledge of medical device quality standards ISO 13485/FDA practices, GMP and similar regulated industry standards.
• Proficient in Microsoft Office Software (Word, Excel, Visio, PowerPoint, MS Project).
• Preferred knowledge of 3D modeling software (Creo, Solid Works).

Physical Requirements:

• Frequently required to sit, stand, walk, and communicate.
• Occasionally lifting with minimal exertion during shift.
• Ability to travel overnight up to 10% of time, if needed.
• Must be able to perform the essential functions of the job, with or without reasonable accommodations.