Process Development Engineer

Posting Date 1 month ago(8/27/2021 11:19 AM)
Requisition ID
Job Location(s)
Bloomington IN United States
Less than 10%
Position Type
Full Time
Cook Medical Holdings


The 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 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).
• Utilize a risk based approach during the development, implementation, and validation of all processes and test methods.
• Responsible for process documentation (PFMEA’s, Production Instructions, Drawings etc.) associated with new products.
• 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, and procure 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 3 years experience working in Class II/III medical device manufacturing environment with Bachelor's or 5 years experience with Master's or 3 years with PhD
• 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

• Working knowledge of Microsoft Office Software (ie Word, Excel, Visio, Power point, MS Project)
• Preferred knowledge of 3D Modeling software (Creo, Solid Works, etc)


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.


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