Process Development Engineer

3 months ago
Requisition ID
Job Location(s)
West Lafayette IN United States
Shift Type
Position Type
Full Time
Cook Advanced Technologies


The Process Development Engineer at Cook Advanced Technologies assumes responsibility for developing pre-market product manufacturing processes.



• Develop commercially viable process for manufacturing products in the premarket phase
• Conduct risk analyses of processing methods and identify steps to minimize risk
• Develop batch qualification methods and procedures for tissue-based products
• Generate documentation to support design control
• Conduct process validations and re-validations according to quality system requirements
• Select and qualify equipment, tools and instruments with the goal of preventing defects, designing for manufacturability and improving product quality
• Write specifications and instructions for manufacturing processes of tissue-based products
• Coordinate product build and delivery for preclinical and clinical studies
• Practice continuous improvement by evolving both the quality system and business processes
• Remain current and apply the understanding of FDA-ISO13485 and quality system requirements in carrying out duties

• Conduct other corporate duties when required.


• Bachelor's degree in Engineering or Science; Masters or PhD preferred
• Understand tissue biology and the effects of tissue handling on biocompatibility
• Able to develop and validate tissue handling processes for manufacturing tissue-based products
• Willing to work with material derived from living tissues
• Able to understand and use CAD drawings - experience in using CAD tools not required, but preferred
• Excellent project management skills; ability to adapt to multiple responsibilities and shifting priorities
• Able to clearly and effectively communicate ideas to a variety of technical backgrounds
• Experience with design control documentation

• Able to work in interdepartmental teams, set goals and work independently to achieve milestones


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