Development Engineer

The Product Development Engineer position at Cook Biotech, Inc. has responsibility for leading discovery and development projects and completing the activities required to advance CBI technology platforms and product designs.

• Work as a member of various project teams under direction of the Engineering Manager to discover new technology platforms and develop new product designs in a timely manner
• Conduct product development activities for new and modified designs according to the CBI Quality System procedures and instructions
• Conduct process development activities necessary to implement new and modified manufacturing processes for both pilot-plant and commercial operations
• Gather critical clinical application information, performance requirements, and end-user needs to support development activities
• Design and coordinate process qualification and design verification testing activities
• Conduct process and design risk analyses according to CBI Quality System procedures and instructions
• Develop and implement new manufacturing documentation
• Effectively communicate project updates to team members, management, and other stakeholders
• Remain current and apply the understanding of FDA, ISO 13485, and ISO 14971requirements in carrying out duties

• Master’s degree in Biomedical Engineering, Chemical Engineering, or related field, or a bachelor's degree with applicable experience
• Recent graduates and candidates with up to 5 years of industry experience preferred
• Proven ability to design and execute experiments intended to support feasibility and development efforts
• Good documentation skills with the ability to appropriately record complex laboratory activities
• Knowledge of or interest in laboratory and manufacturing equipment and manufacturing processes common for biomaterial processing
• Able to work both independently and as a member of a team depending on the needs of the project
• Good task and time management skills with the ability to work on multiple projects simultaneously
• Able to effectively communicate task status and project updates to team member, management, and other stakeholders
• Able to receive and appropriately act upon ideas, suggestions, and feedback from peers, managers, and other stakeholders
• Willing to work with material derived from animal tissues
• Sufficient background to generally understand medical and biotechnology terminology
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