This is for a medical device contractor that grew by more than 40% in 2018 and their growth is continuing.
Design and develop prototype medical textile based structures and processes to demonstrate feasibility for meeting customer needs.
Develops products based on customer needs and specifications.
Researches and implements new technologies/capabilities required to meet customer's needs
Duties and Responsibilities:
Works independently under the direction of the Director.
Interact with customers, medical device engineers and sales team to understand the unmet needs and offer solutions.
Selects preliminary materials, manufacturing techniques in developing textile components and related value added processes.
Develops costing for processes.
Leads the selection and development of new technologies, equipment, capabilities and processes.
Interact with outside vendors, suppliers, and consultants.
Provide technical support to sales, customers and operations.
Occasionally may develop and execute design and process validation activities including IQ, OQ and PQ protocols, testing and reports.
Supports the creation of risk management and design control documents – per ISO 13485 including process flow charts, PFMEA, and control plans.
Education and /or Experience
BS or MS in Mechanical Engineering, Biomedical Engineering, Textile Engineering or equivalent.
Minimum of 10 years developing textile solution for new products with focus on process development and validation related activities. Ideally covering braiding, knitting, weaving, and non-woven.
Have passion and enthusiasm for innovation.
Strong mechanical aptitude for creating new capabilities is preferred.
Hands on aptitude to dive in and develop processes that are robust and transferable to manufacturing . Must be capable of handling multiple projects/tasks at the same time.
Proven problem solving skills
Minimum of 3 years' experience in a regulated industry. Medical device preferred.
Experience working with bio-absorbable polymer based implantable medical devices preferred.
Experience in the cardiovascular and/or orthopedic implantable medical device industry preferred.
Knowledge of Design/Process Excellence (Six Sigma black belt certified is a plus) preferred.