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 needed engineering controls for class II medical devices.Developed app-controlled medical device in accordance with FDA established… Show more 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 needed engineering controls for class II medical devices.Developed app-controlled medical device in accordance with FDA established guidelines for SAMD (Software As a Medical Device).Remediated audit findings associated with engineering documentation for marketed products. Show less

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 time and budget constraints.• Coordinated research and development… Show more • 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 time and budget constraints.• 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. Authored FDA regulatory submission for device portion of combination product.• 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.• Designed and led survey with Key Opinion Leaders in the medical field to determine optimal site for device implantation in humans.• Led effort to design novel aseptic loading fixture to transfer living cells into class III medical device while excluding the possibility of contamination from micro-organisms.• Led team to develop surgical technique to be utilized in phase I clinical trial. Additionally, drove design effort of dedicated surgical instruments to be used in later-phase clinical trials. Show less

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 methods for prototype medical devices employing nanosurface technologies for Ethicon, Codman, Vistakon and DePuy.Conceived and… Show more 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 methods for prototype medical devices employing nanosurface technologies for Ethicon, Codman, Vistakon and DePuy.Conceived and championed innovative concept for sleep therapy device.Trained in Flawless Project Execution (FPX). Show less

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 ModelingIntellectual Property DevelopmentCompleted Johnson & Johnson Management Course.Partnered with Johnson & Johnson… Show more 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 ModelingIntellectual Property DevelopmentCompleted Johnson & Johnson Management Course.Partnered with Johnson & Johnson operating companies DePuy Spine and Codman to perform specialized research and development. Led teams to develop new bioabsorbable functional prototypes to support on-time execution of seven preclinical protocols.Worked with Regulatory Affairs, Corporate Product Characterization, Quality Assurance, and Marketing functions to support product development and commercialization.Three patents issued and six patents pending for work in tissue engineering.Compounded pharmaceutically-active ingredients into bioabsorbable structures Show less

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 several proprietary tissue-engineering initiatives, developed new bioabsorbable functional prototypes to support on-time… Show more 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 several proprietary tissue-engineering initiatives, developed new bioabsorbable functional prototypes to support on-time execution of six preclinical protocols. Routinely updated management on project status via written reports and staff meeting presentations.Johnson & Johnson Certified Six-Sigma Black Belt - August 2003. Show less

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 Resources to develop new surgical products and support continual product improvement of existing sutures.Authored Process… Show more 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 Resources to develop new surgical products and support continual product improvement of existing sutures.Authored Process Specifications, Operating Procedures, and Test Methods necessary for suture manufacturing.Transferred processes and test methods developed in laboratory to full-scale manufacturing, assuring on-time product launches for two different suture types. Show less

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 composite materials with thermoplastic matrices, including Liquid Crystal Polymers (LCPs) for sporting goods and medical device… Show more 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 composite materials with thermoplastic matrices, including Liquid Crystal Polymers (LCPs) for sporting goods and medical device applications.Managed a group of technicians.European and American patents granted for work on PPT (Poly-1,3-Propylene Terephthalate). Show less

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