David Frank Email & Phone Number

Northport, Ny, Us

Northport, Ny, Us

Shirley, New York, United States

Shirley, New York, United States

Shirley, New York, United States

•Developed and implemented biomaterial refinement process improvements, including automated material cutting, convection freezing and single-use bioreactor systems, satisfying AATB, FDA & ISO regulations. •Construction and validation of new production facility including an ISO Class 7 clean room with ISO Class 4 flow booths, a USP Purified Water system feeding steam sterilizers and cabinet washers, ultra-low freezing and thawing equipment, and automated mixer systems with sterile single-use chemical solution dispensing. •Represented Operations Engineering on product development teams to ensure smooth design transfer. •Implemented Blue Mountain Regulatory Asset Manager for scheduling of equipment preventive maintenance and the tracking/trending of unscheduled equipment repairs.

•Responsible for design of high-end, decorative kitchen and bath fittings and accessories. •Managed projects from concept through mass production including initial solid modeling, 3D printing of plastic prototypes, design optimization, drafting of machine drawings, in-house production of mock-up samples and international out-sourcing of final designs. •Interfaced with architects, industrial designers, machinists, factory employees, construction managers and plumbers to guarantee smooth installation of custom designs.

•Developed, qualified and validated multiple manufacturing processes, including biomaterial processing, plastic device assembly and packaging operations, within a manufacturing environment, satisfying internal QC, and FDA/ISO regulations. •Optimized refinement of bovine collagen, from raw tendon through lyophilization, into a sponge plug for use in a Hemostatic device. •Represented Manufacturing engineering on a design team developing a sheathless Chronic Hemodialysis Catheter utilizing an over-the-wire insertion technique. •Implemented an automated Machine Vision system, based on DVT's SmartSensor technology, to increase efficiency and remove human element from visual product inspection. •Aided in construction and validation of an ISO Class 7 clean room environment, including organization of equipment transfer and all required standard operating procedures from gowning procedures to floor plan updates to environmental sampling programs.