Cook Medical Product Development Engineer in west lafayette, Indiana
The Product Development Engineer position at Cook Biotech, Inc. has responsibility for leading discovery and development projects and completing the required activities intended to advance CBI technology platforms and product designs that meet clinical needs and customer requirements.
• Work as a member of various project teams under direction of the Engineering Program 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• Coordinate the effective transfer of projects to Operations• Effectively communicate project updates to team members, management, and other stakeholders• Remain current and apply the understanding of FDA-ISO 13485 and quality system requirements in carrying out duties• Remain current and apply the understanding of ISO 14971
• Master’s degree in Biomedical Engineering, Chemical Engineering, or related field, or a Bachelor's with applicable experience• 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
• Must be able to perform the essential functions of the job, with or without reasonable accommodations• Limited exposure to hazardous chemicals used in the manufacture of the product• Physical demands are typical of an office and laboratory environment
Job Location(s)West Lafayette IN United States
Position TypeFull Time
CompanyCook Biotech Inc.