Joe Hammer Email & Phone Number

New Jersey, United States

New Jersey, United States

Medical Device Consultant specializing in Design History File Remediation for Medical Devices. Review key Design History File documentation to assure compliance with internal and external requirements.

New Jersey

Medical Device Consultant specializing in Design History File Remediation for Combination Products. Review key Design History File documentation to assure compliance with internal and external requirements.

Morristown, NJ

Led team of three individuals of diverse backgrounds and skill sets (mechanical engineering, electrical engineering, and cell biology) to develop and launch class I and class II medical devices. Provided design and engineering support to enable filing of multiple FDA 510(k) submissions.Developed numerous SOPs, OIs and other documentation to support the.

New Jersey

• Led development activities at external vendors for immune-isolation device portion of a combination product (Biologic – Device) for preclinical studies to provide compelling evidence for clinical trials.
• Directed Design and Manufacture process of Class III implantable medical device and support equipment, including functional preclinical and clinical prototypes. Established and delivered project deliverables within.
• Coordinated research and development… Show more
• Coordinated research and development efforts with other disciplines targeting entry into a phase I clinical trial for a combination product. Disciplines involved include quality, regulatory, clinical and preclinical..
• Utilized principals of design control to properly document and revise design process as required (CTQ flowdown). This documentation is required information for regulatory submission.
• Managed contract organization responsible for the design and production of functional preclinical and clinical device prototypes.

Led team to develop radiopaque formulations of existing implantable medical device for DePuy Spine. Partnered with Marketing and Regulatory functions to establish product requirements and regulatory pathways.Contributed materials and processing expertise to assure product launch of bone tissue scaffold material.Responsible for determining manufacturing.

Managed a group of Materials Science professionals and deployed them into regenerative therapeutic and tissue engineering related projects according to their skill sets and development needs. Specifically, managed these skill sets for multiple projects:Materials and Process EngineeringAnalytical and CharacterizationMechanical AnalysisComputer.

Partnered with Johnson & Johnson operating companies DePuy Orthopaedics and Ethicon Endo Surgery to perform specialized research and development.Developed new and unique medical devices from bioabsorbable materials in the form of lyophilized foams, nonwovens, and braided structures. Transferred prototype production to manufacturing.As project leader for.

Managed a group of research associates.Designed Experiments to characterize physical properties of fibers fabricated from bioabsorbable (Lactide, Glycolide, and/or Caprolactone-based) and non-absorbable polymers. As Extrusion Processing Engineer, worked closely with Polymer Scientists, Textile Engineers, as well as Coating, Packaging, and Sterilization.

Evaluated fibers in various applications including mooring lines, racquet strings, tire cord, fiber optic cable reinforcement, specialty electrical insulation and others.Produced prototypes of unique sheath/core filament yarns from multiple polymers utilizing co-extrusion processing techniques and equipment.Developed carbon and glass fiber-reinforced.

Responsible for material (such as metal alloys, polymers, adhesives, and surface finishes) and process (such as machining, welding, bonding, and metal plating) requirements for avionics systems.

Master Of Engineering

Engineering

Bachelor Of Engineering, Mechanical Engineering

Mechanical Engineering