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.
Responsibilities- 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.
- Minimum Bachelor's degree in Engineering or Engineering Technology • Preferred minimum 3 years experience working in 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 ISO13485/FDA practices, GMP and similar regulated industry standards
- Proficient in Microsoft Office Software (Word, Excel, Visio, Power point, 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 over-night up to 10% of time, if needed.
- Must be able to perform the essential functions of the job, with or without reasonable accommodations.
Top Skills
What We Do
At Cook, we are building our future on Invention, Connection, People, and Community.
As a privately owned company, we can look at the world our own way and do what we feel passionate about. What are we passionate about? That’s simple: Making unique, quality products and connecting with people to improve lives on both sides of the device.
Central to our focus on building deep connections is our belief in the importance of identifying innovative solutions to help customers, patients, employees, and communities thrive. We understand that our ongoing success will come from creating inclusive, supportive, and healthy environments where we can prosper together. Our people are our greatest asset and are at the heart of everything we do. Come build with us.
