Senior Engineering - Medical Products
We are conducting a search for a Senior Engineer, with responsibilities in supporting new Cell Therapy products. This key position will support the development and implementation of new products and processes in accordance with company?s product development process. The Sr. Engineer will lead technology transfer and start-up activities, provide investigations support, analyze process data, and identify and implement process improvements. This position requires technical expertise as well as a general knowledge of design control and project management. The Sr. Engineer exercises independent judgment in scientific development methods, techniques and evaluation criteria for obtaining results. This position will be critical in insuring a high level of quality and safety of our products.
? Responsible for the design transfer from development to manufacturing and associated verifications and validations.
? As a core team member for product development and process improvement projects, work effectively with R&D Operations, Quality, Safety, Planning, and production business unit(s) to develop and implement new products, processes.
? Interact with vendors as part of supplier management process for new equipment, parts, or material purchase, and evaluating products according to quality standards and specifications.
? May have responsibility for overseeing the workmanship of support or junior staff including training
? Reviews and edits internal documentation for team members and assists in the preparation and presentation of materials for internal or external technical reviews
? Work closely with internal Manufacturing, Manufacturing Engineers and Quality Engineers to develop manufacturing plans
? Consider company capabilities, state-of-the-art parameters, and technical possibilities for each project
? Participates in establishing a collegial network of internal technical experts with potential to providing scientific guidance
? Keeps abreast of current technologies in area of specialty including that of the tissue processing and engineering field
? Provide technical leadership in developing PMA, BLA submittals and processes.
? Process development engineer with focus on cells. Ideally a BS/MS in biomedical engineering or equivalent, with preference in implantable materials, tissue engineering or mechanicalengineering development of mechanical medical products.
? Must have solid experience with BLA or PMA pathways, ideally CMC (Chemistry, Manufacturing and Controls) activities preferred.
? 5 years in industry/regulated (GMP) environment with cellular background preferred
? Solid experience in process characterization, DOE, product development through to manufacturing scale-up.
Key Core Competencies Include:
1. Technical Knowledge
2. Process Improvement & Innovation
3. Critical Thinking and Problem Solving
4. Results Oriented
6. Quality Focus
7. Customer Focus
Compensation is highly attractive and includes bonus and relocation. Please contact Art Rogove, VP at Merit Consulting, phone 904-436-6101 or at .