Responsible for the oversight and execution of all R&D and Product Development activities. Will provide leadership and direction to researchers, and engineers, and help guide new product and process development initiatives. Will also apply R&D skill set using scientific and engineering background, to help improve manufacturing processes and optimize yields.
The on-going development of novel R&D projects and ideas in the tissue, biologic, and medical device markets will be required in order to differentiate and further develop product offerings.
- Responsible for Tissue Bank Research and Development activities, including new product development and enhancement of existing products and or processing methodologies.
- Manage Department activities throughout the development process related to initial product/process concept, development, verification/validation, testing, and manufacturing.
- Provide direction, leadership, and training to the Development team.
- Manage R&D activities to develop novel allograft, medical device, and biologic offerings, new processing methods, and process improvements.
- In collaboration with the VP Sales and Marketing, develop pathway to commercialize new or improved uses of donated tissue, including processing methods, preservation, packaging and the development of marketing data and materials.
- In collaboration with VP Quality, provide data to support the regulatory classification of allografts.
- Manage Product Development activities to maximize yields and ensure manufacturability.
- Help support training activities during design transfer of new products.
- Assist in the development of QC inspection procedures for finished product inspection.
- Maintain and improve existing products and processes.
- Coordinate product development activities with medical device customers.
- Perform and coordinate product testing of allografts, biologics, and medical devices as applicable.
- Develop and implement SOP’s as appropriate.
- Support facilities management in preventative maintenance program as it relates to new product development and existing processing activities.
- Troubleshoot production processes and product issues.
- Analyze tissue utilization rates and develop strategies to maximize the use of all available tissue through the use of manufacturing techniques and the development of alternate uses of tissue.
- Master’s Degree in Biomedical Engineering, Materials Science, or equivalent, Doctoral degree preferred.
- Must have extensive scientific background in biomaterials and process development.
- Must have a minimum of five years’ experience with medical device, biologic, or tissue product development.
- Must be knowledgeable in FDA, State, and Federal compliance and validation processes.
- Demonstrated physical ability to lift, carry and/or move equipment of varying weight from 1 to 30 pounds for 10% of the work time and to stand for periods of the work time.
- Demonstrated interpersonal skills and professional attitude necessary to interact and communicate effectively with other members of the tissue team and with hospital services and other external agency personnel.