David Mcnally Email & Phone Number

Phillipsburg, Nj, Us

• Provide medical device project development knowledge and expertise to guide and direct all medical device projects within BihlerMED. • Train, develop and collaborate with mechanical engineering and production operators to form a cohesive project team to drive project deliverables and boost efficiency to meet constantly shifting priorities and deadlines.• Manage new product development, validation activities, production scheduling, inventory/purchasing, equipment design and… Show more • Provide medical device project development knowledge and expertise to guide and direct all medical device projects within BihlerMED. • Train, develop and collaborate with mechanical engineering and production operators to form a cohesive project team to drive project deliverables and boost efficiency to meet constantly shifting priorities and deadlines.• Manage new product development, validation activities, production scheduling, inventory/purchasing, equipment design and manufacturing priorities for all clean room and production processing.• Practice cGMP in an ISO 13485 and ISO 9001 certified company to ensure quality of manufactured medical devices exceeded industry standards. Show less

United States

• Guide start-up companies in the design, development and FDA submission of Class I and II medical devices primarily focused in surgical lighting and complex assembly.• Implement creative manufacturing solutions to move from prototype to large scale manufacturing in an expedited timeline.• Develop and execute IQ/OQ/PQ Validations for self-designed equipment and processes to meet customer demand.

Parsippany, Nj

• Design and development of complex specialty surgical instruments across the full portfolio of combined products for the newly integrated Zimmer Biomet.• Collaborate with sales, product development engineering, quality, regulatory, manufacturing and outside vendors to expedite manufacturing and delivery of surgical instruments of varying complexity with minimal lead time.• Manage all aspects of 3D printed prototypes to provide demonstration of instrument design for surgeon review and… Show more • Design and development of complex specialty surgical instruments across the full portfolio of combined products for the newly integrated Zimmer Biomet.• Collaborate with sales, product development engineering, quality, regulatory, manufacturing and outside vendors to expedite manufacturing and delivery of surgical instruments of varying complexity with minimal lead time.• Manage all aspects of 3D printed prototypes to provide demonstration of instrument design for surgeon review and approval, including material research, budgeting, scheduling and maintenance.• Research and implement new materials and technologies in instrument design to achieve innovative solutions for surgical needs and improve the quality of care provided to the patient. Show less

Parsippany, Nj

• Design and development of specialty surgical instruments for use in thoracolumbar, cervical, minimally invasive and inter-body applications.• Recording of design changes and mechanical strength analysis through engineering evaluation documentation in compliance with FDA regulations.• Rapid design iteration in a fast paced working environment to implement timely and cost effective products to meet strict surgeon requirements.

Eatontown, Nj

• Identify key restricting areas in production and design solutions to meet current and future throughput goals.• Design, manufacture, and test prototypes by following the stages of design for ongoing process improvement initiatives and utilize computer aided design where applicable. • Construct and maintain all current documentation to meet project and customer requirements including drawings, bill of materials and manufacturing procedures to accompany new design… Show more • Identify key restricting areas in production and design solutions to meet current and future throughput goals.• Design, manufacture, and test prototypes by following the stages of design for ongoing process improvement initiatives and utilize computer aided design where applicable. • Construct and maintain all current documentation to meet project and customer requirements including drawings, bill of materials and manufacturing procedures to accompany new design implementation.• Train, manage and engage with operational technicians from all production departments to improve overall project deliverables and boost efficiency to meet constantly shifting priorities and deadlines• Develop and execute IQ/OQ/PQ Validations for self-designed equipment and processes.• Practice cGMP in an ISO 13485 and ISO 9001 certified company to ensure quality of manufactured medical devices exceeds industry standards. Show less

Pennington, Nj

• Manufacture parts from engineering drawings to tight tolerances ensuring low material waste.• Consult on design projects to provide insight on the manufacturing process and machining timeline.• Maintain machinery including Mills, Lathes, Drill Press, Band Saw, etc.• Manage inventory of materials and fasteners including budgeting, sourcing and scheduling.

An interdisciplinary senior project team working to develop a single leg exo-skeletal walking assist device for those with weakness in the lower extremities. Working on motor, planetary gearing and drivetrain design while assisting with frame articulation, research, and report preparation.

Worked as part of a multi-disciplinary team under a grant from the New Jersey Space Grant Consortium and NASA. Contributed knowledge of the field of Biomedical Engineering towards the goal of designing a zero-gravity exerciser that would reduce the effects of muscular atrophy during space flight.