The Process Development Engineer is responsible for the designing and optimizing of 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 in order 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 (within Cook Medical facilities and/or with third party suppliers) required for the development and manufacture of new device designs.
• 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 (PFMEA’s, Validation Plans, Production Instructions, Drawings etc.) associated with new production processes
• Liaise with 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 team, 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
• Ability to complete projects within specific time lines, costs, 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
• Bachelor's 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.
• 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)
• 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.
Software Powered by iCIMS