The Senior Process Development Engineer is responsible for the designing and optimizing of processes 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 (within Cook Medical facilities and/or with third party suppliers) required for the manufacture of new device designs.
• Execute methods needed for efficient and effective process development (design for manufacturing, process validation, process capability, lean manufacturing, equipment selection and specification development).
• Ensure that a risk based approach is applied during the development implementation and validation of all processes.
• Ensuring that the principles of Design for Manufacture, and Lean manufacturing are central to the R&D process and designs.
• Liaise with production engineering for process engineering layout plans and implementation in relation to new processes and production lines.
• Responsible for process documentation (PFMEA’s, Production Instructions, Drawings etc.) associated with new products.
• Collaborate with other R&D teams, Operations, and Production engineering to ensure the effective completion of all activities associated with an R&D Engineering project / objective.
• Compare costs and benefits when choosing product in-house or supplier selection.
• Design and optimize process and process equipment for large and small scale manufacturing.
• Ability to complete projects within specific time lines and meeting performance expectations.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
• Must maintain all training re quirements for the position, while seeking out opportunities for continuous development and growth.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Must strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Must maintain company quality and quantity standards.
• Must have effective communication skills, which may include oral or written
• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal
• Ability to remain calm and receptive in fast paced situations.
•Bachelor's degree in Engineering, or related field is required.
• Minimum 5 years experience working in Class II/III medical device manufacturing environment.
• Strong knowledge of process validation, design for manufacturing, statistics and lean manufacturing principles.
• Strong knowledge of medical device quality standards ISO13485/FDA practices,GMP and similar regulated industry standards.
• Proficient in Microsoft Word/Excel/Outlook.
• Frequently required to sit, stand, walk, and communicate.
• Occasionally lifting with minimal exertion during shift.
• Ability to travel over-night up to 10% of time, if needed.