Expert in Medical Device Engineering
Expert ID: 734924 California, USA
He worked on packaging processes of medical devices such as implantable catheters.
He worked on packaging materials of medical devices such as plastic packaging.
He worked on manufacturing automation of medical devices such as silicon micromachined pressure transducers.
He worked on irradiation sterilization of medical devices such as biochemical sensors.
He worked on manufacture problem solving of medical devices such as soldering.
He worked on manufacture in clean rooms of medical devices such as catheter manufacture.
He worked on intellectual property of medical devices such as implantable pumps.
He worked on evaluation of medical devices such as biochemical sensors.
He worked on development of medical devices such as sensors.
He worked on corrosion of medical devices such as metals on implantable sensors and sensor packages.
He worked on coating materials for medical devices such as anti-thrombogenic coatings for implantable catheters.
He worked on disposable medical devices such as plastic syringes.
He worked on device engineering of medical devices such as implantable pumps.
As a consultant, Expert has undertaken the following work:
Optimizing design and manufacturing welding process of valve for long term implantable chronic pain pump.
Optimizing design and manufacturing bonding process of radiopaque platinum tip for long term implantable silicone catheter.
Designing and developing next generation subcutaneous glucose sensors for external insulin pumps.
Developed designs of silicone rubber parts for sensor assemblies and sensor test systems.
Mechanical device design and silicone molded part design and fabrication for a device used for sample preparation and processing of biomolecules.
Materials and process development for an electromagnetic coil for an implantable micro-pump. Device pumps drug into the eye for glaucoma patients.
Selected and verified materials to be used for medical device assemblies including silicone rubbers, thermoplastics, epoxy adhesives, and UV cure adhesives.
Designed molds and molding processes for silicone rubber parts
Designed tooling and processes for thermally sealing small plastic sensor assembly parts.
Characterized and validated tools and processes for thermally sealing small plastic sensor assemblies.
Design and development of optical glucose sensors, fiber optic/membrane bonding materials and methods. Mechanical design of fiber optic cutting tools, polishing tools.
Process and mechanical tool design for dipping glucose permeable membranes for a fiber optic sensor.
Selection and development thin polymer film (polyimide, etc.) and thickness measurement equipment selection. Development and selection of polyimide release from glass process and equipment selection (UV nanosecond and picosecond lasers).
Development and selection of light blocking polymer blends to block extraneous light from interfering with optical detector.
Process development of extruded and spray coated polymer membranes for optical glucose sensor.
Mechanical design and materials selection of radiation shields (tungsten alloys) to block e-beam radiation. Selection of chemical etch equipment for thin film metals on polymer substrates.
|Year: 1980||Degree: Bachelor of Science||Subject: Chemistry||Institution: Northeastern University|
|Years: 2008 to Present||Employer: Undisclosed||Title: Vice President||Department:|
Responsibilities:Medical device design, development, and manufacture of implantable biochemical sensor (glucose)
Implantable drug pump, chronic pain (morphine), mechanical design, silicone molding.
Evaluated and optimized platinum to silicone bond for long term implanted catheter.
Evaluated and optimized titanium/silicone valve seal used on morphine pump.
Evaluated and long term viability of pumping mechanism for morphine pump.
|Years: 2003 to 2008||Employer: Osmetech Molecular Diagnostics||Title: Principal Staff Research Engineer||Department: Engineering|
Responsibilities:Designed cartridge assembly for an electrochemical DNA biosensor array platform.
Providing critical design inputs to outside design firm to facilitate development of new micro fluidic platform.
Managing key suppliers of printed circuit boards and molded parts
Managing equipment engineering and Manufacturing engineering.
|Years: 2000 to 2003||Employer: Futura Medical Technologies, Inc.||Title: Director of Engineering||Department: Engineering|
Responsibilities:Directed a multidisciplinary product development team to design and develop a 3cc retractable needle safety syringe. Planned and scheduled milestones for design, drawings, mold fabrication, part fabrication, and syringe manual-assembly tools, and fixtures.
Directed a multidisciplinary product development team to incorporate above design improvements from 3cc program into the next generation program to develop a 1cc safety syringe now ready for production phase of development.
|Years: 1997 to 2000||Employer: Medical Research Group, Inc.||Title: Senior Engineer||Department: Engineering|
Responsibilities:Designed smaller diameter sensor for use as a subcutaneous (or other implant site) sensor.
Managed design, drawings, mold and part, connector, and sensor assembly fabrication.
Developed formulation and synthesis of a cross-linked glucose oxidase matrix for glucose sensing in blood.
Managed program to develop braze profiles to produce effective braze of refractory metal onto ceramic used to create hermetically sealed assemblies.
|Years: 1995 to 1997||Employer: McConnell Montalvo & Associates, Inc.||Title: Vice President||Department:|
Responsibilities:Selected materials for design and development of a new patented implantable drug infusion pump.
Designed and developed materials and processes for new patentable cochlear lead.
Designed and developed molds and tooling to make parts for angioplasty catheters.
Designed and developed materials and processes to make hypoallergenic synthetic rubber catheter balloons.
|Years: 1992 to 1995||Employer: Ohmeda Inc.||Title: Principal Engineer||Department: Engineering|
Responsibilities:Developed next generation silicon micro machined disposable blood pressure transducers
Member of a team that created a transducer assembly design and automation equipment to assemble the next generation blood pressure transducers.
|Years: 1987 to 1992||Employer: Siemens-Pacesetter Inc||Title: Senior Development Engineer||Department: Engineering|
Responsibilities:Developed implantable sensors for closed loop control of external and implant¬able pumps.
Developed sensors and catheter assemblies for pacing and implantable defibrillation.
Developed biocompatible materials and coatings and processes for surface modification.
Researched new technologies and methods for sensor feedback control in pacing and implantable cardio defibrillation.
Designed and prototyped mechanism for patented air sensor system.
|Associations / Societies|
|Member of American Chemical Society
Member of Society of Manufacturing Engineers
|Engineers' Council, Board member, Charitable Giving|
|Publications and Patents Summary|
|Expert holds 5 U.S. patents, including two in fluidic devices.|
|Training / Seminars|
|Statistical Process Control, Failure Modes and Effects Analysis, SolidWorks, SPSS statistical software|
|thermoplastic injection molding- Apex medical; silicone rubber Transfer molding-Rolenn manufacturing; Printed circuit boards-Sanmina; Thin film deposition-Thin Film Technologies; Adhesives-Epoxy Technology-Dymax Inc.; Thermoplastic extrusion- Microspec Inc.;|
|Other Relevant Experience|
|Expert's experience includes: Silicone rubber transfer molding and mold design, thermoplastic molding and mold design, SolidWorks computer aided design, MiniTab statistical software, adhesives materials and processes, and soldering materials and processes.|
Fields of Expertise
medical device hazard analysis, medical device packaging process, medical device packaging material, medical device manufacturing automation, medical device irradiation sterilization, medical device manufacturing troubleshooting, medical device manufacture clean room, medical device patent, medical device evaluation, medical device product development, medical device corrosion, medical device coating material, disposable medical device, biomedical device engineering, antimicrobial medical device, medical device shelf life, medical device inspection, plastic medical device, medical device endurance testing, biomedical device design review, medical device reliability testing, medical device process validation, medical device mechanical stress analysis, medical device manufacturing quality control, FDA medical device regulation