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 Expert  723350

Expert in Adhesives for Medical Device, Biotech, Pharmaceuticals, Aerospace, Materials Science, QA, QC


Available for your Consulting and Expert Witness Needs

California (CA)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
With a PhD in organic chemistry expert has spent over 25 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. Some of thse involved acrylic resins especially as it relates to PSAs (pressure sensitive adhesives. In addition, Expert holds 3 patents in the area of adhesives.

Expert has spent over 15 years developing adhesives, resins and advanced composites for a variety of applications. Expert started at the bench chemist level and worked my way up into R&D management. In addition, he holds 3 patents in the area of adhesives and advanced composites. Much of the time developing adhesives was focused on the highly demanding Aerospace quality adhesive. During this time at companies like Lockheed Martin much emphasis was placed on post mortems failure analysis. In the process he further refined his expertise in the area of adhesion science and surface analysis.

Much of the time developing adhesives was focused on the highly demanding Aerospace quality adhesive. During this time at companies like Lockheed Martin much emphasis was placed on post mortems failure analysis. In the process expert further refined his expertise in the area of adhesion science and surface analysis. Much effort was also placed on the aging of adhesives and therefore adhesion loss as companies like Lockheed Martin and Boeing try and increase to life of their inventory.

Expert has spent over 15 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked my way up into R&D management. In addition, he holds 3 patents in the area of adhesives and advanced composites. Much of the time developing adhesives was focused on the highly demanding Aerospace quality adhesive. This meant developing formulations with good adhesion. Formulation development was an essential part of his job function for many years and expert had to learn how to formulate for maximum adhesion through the use of adhesion promoters, etc.

Much of the time developing adhesives was focused on the highly demanding Aerospace quality adhesive. This meant developing formulations with good adhesion. Formulation development was an essential part of expert's job function for many years and he had to learn how to formulate for maximum adhesion through the use of adhesion. During this time at companies like Lockheed Martin much emphasis was placed on post mortems failure analysis. In the process he further refined his expertise in the area of adhesion science and surface analysis.

As with developing adhesives, he gained expertise in the areas of testing adhesives. This included the typical mechanical test methods of tension, flexure, peel, compression to more complicated method like toughness. Some aerospace applications were also concerned with out gassing and so he also added that to his testing expertise. These tests were dynamic and at times included fatigue testing under very different environments from ambient to hot wet conditions and salt spray, etc.

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acrylic resin

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adhesion

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adhesion loss

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adhesion promoter

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adhesion science

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adhesion testing

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adhesive failure analysis

To successfully develop adhesives, you need to know something about adhesion theory. Much of adhesion theory has to do with surface chemistry and topography of the surface. It was always a goal to increase the adhesive strength. Knowing the theory of adhesion and seeing SEM photos was an essential element in that process.

Much of his time developing adhesives was focused on the highly demanding Aerospace quality adhesive. This meant developing formulations with good adhesion. These were typically thermoset adhesives that required curing such as epoxies, bismaleimides, polyimides, etc. Developing the cure cycle was an essential part of the adhesive development. Formulation development was an essential part of expert's job function for many years and hs had to learn how to formulate for maximum adhesion through the use of adhesion. During this time at companies like Lockheed Martin much emphasis was placed on post mortems failure analysis. In the process he further refined his expertise in the area of adhesion science and surface analysis. Expert also developed adhsives for other applications that included commercial as well as some medical device medical applications. Knowing the application is essential to developing the right adhesive.

Formulation development was an essential part of expert's job function for many years and he had to learn how to formulate for maximum adhesion through the use of adhesion. During this time at companies like Lockheed Martin much emphasis was placed on post mortems failure analysis. In the process he further refined his expertise in the area of adhesion science and surface analysis. He also developed adhsives for other applications that included commercial as well as some medical device medical applications. Knowing the application is essential to developing the right adhesive. During expert's work history he served in a variety of process development roles as they relate to adhesives. This included the fabrication of medical devices at Affymetrix. In this application he had to "customize" equipment to dispense an acrylic adhesive in a precise geometry and of a precise weight around an optical window. Other applications of adhesive dispensing were in Aerospace applications where, like with medical devices, location and quantity of adhesive were critical.

Expert has spent over 15 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. In addition, expert holds 3 patents in the area of adhesives and advanced composites. Much of the time developing adhesives were focused on the highly demanding Aerospace quality adhesive. This meant developing formulations with good adhesion. Formulation development was an essential part of his job function for many years and he had to learn how to formulate for maximum adhesion through the use of adhesion. During this time at companies like Lockheed Martin much emphasis was placed on post mortems failure analysis. In the process he further refined his expertise in the area of adhesion science and surface analysis. Expert also had to formulate for the job requirements such as hot wet environments or electrical properties (either a conductor or insulator).

Expert has spent over 15 years developing adhesives, resins and advanced composites for a variety of applications. Expert started at the bench chemist level and worked his way up into R&D management. In addition, he holds 3 patents in the area of adhesives and advanced composites. Over these years he worked closely with manufacturing and in some positions was responsible for manufacturing of the adhesvices (thermset).

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adhesion theory

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adhesive application

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adhesive curing

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aerospace adhesive

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adhesive dispensing equipment

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adhesive formulation

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adhesive manufacturing

As with developing adhesives, he gained expertise in the areas of testing adhesives. This included the typical mechanical test methods of tension, flexure, peel, compression to more complicated methods like toughness. Some aerospace applications were also concerned with out gassing and so he also added that to his testing expertise. These tests were dynamic and at times included fatigue testing under very different environments from ambient to hot wet conditions and salt spray, etc. He also supplied adhesives into applications where their elctrical properties (either conductor or insulator) were of critical importance. As a result, he also got involved in testing for these properites as well as optical properties like fluorescence.

Expert has spent over 15 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. In addition, he holds 3 patents in the area of adhesives and advanced composites. Much of the time developing advanced composites was focused on the highly demanding Aerospace requirements that varied from commercial aviation to space vehicles, satellites, and missiles at all of the major aerospace companies.

Expert has spent over 15 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked my way up into R&D management. In addition, he holds 3 patents in the area of adhesives and advanced composites. Much of the time developing advanced composites was focused on the highly demanding Aerospace requirements that varied from commercial aviation to space vehicles, satellites, and missiles at all of the major aerospace companies. Expert was on both sides of advanced composites: the developer and the user. As a result he has a great deal of knowledge on all aspects of the technology. This includes failure modes and mechanical testing.

As a PhD chemist, he supplied advanced materials such as adhesives and composites into all of the major aerospace companies. He also worked for Boeing and Lockheed Martin where he had groups responsible for the use of advanced materials that included metals and non-metals. These non-metals were often specialized coatings for a variety of different applications including heat, radar absorbing, etc.

Expert started working in the labs. He was trained to analyze data and my skills eventually lead me into technical QA roles. His first involvement was providing leadership to a company supplying materials into the circuit board industry. Then at Lockheed Martin he served in a variety of Materials/QA roles where he had the responsibility to look at data and draw conclusions. This lead to a complete transition in technical QA roles within the medical device and pharma industries. In all of those applications he used his technical skills at reviewing data to make informed QA decisions.

With autoclave two areas of his career come to the surface. The first has to do with curing of advanced composites and adhesive. These thermosets were often cured in an autoclave. The second has to do with his experience in the medical device/pharma/bio pharma part of my career. Here autoclaves were standard for sterilization of equipment and materials typically used in packaging of the products. He is very familiar with both very different applications.

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adhesive testing

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advanced composite

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advanced composite technology

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aerospace coating material

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aerospace engineering

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analytical data quality assurance

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autoclave

Expert has spent over 15 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked my way up into R&D management. In addition, he holds 3 patents in the area of adhesives and advanced composites. Much of the time developing adhesives was focused on the highly demanding Aerospace quality adhesive. This meant developing formulations with good adhesion. These were typically thermoset adhesives that required curing such as epoxies, bismaleimides, polyimides, etc. Developing the cure cycle was an essential part of the adhesive development. Formulation development was an essential part of my job function for many years and he had to learn how to formulate for maximum adhesion through the use of adhesion. During this time at companies like Lockheed Martin much emphasis was placed on post mortems failure analysis. In the process he further refined my expertise in the area of adhesion science and surface analysis. He also developed adhsives for other applications that included commercial as well as some medical device medical applications. Knowing the application is essential to developing the right adhesive.

Expert has worked in the medical device industry with such materials as collegan which was derived from a bovine and a human source. The human source involved the culture of human cells on a mesh. The processing of the collegan from the cells would be considered bioprocess engineering. He was responsible for developing new processes and improved processes. All of this was done in clean room environments as low as class 100. This was considered an aseptic process.

His experience with advanced composites covers continuous fiber and short fiber composites. He worked extensively with carbon fiber composites primarily for aerospace applications. Other fiber include glass, Kevlar, Boron. In developing composite materials for the aerospace industry it was part of Expert's job to test these materials to ensure that they meet the demanding requirements. As a result, he became very familiar with the various mechanical test methods (tension, compression, flexure, toughness, etc.) as well as some more exotic testing as required. Working at Lockheed Martin he was also on the other side using these materials. There he continued to gain expertise with testing of the composites being fabricated.

For most of his career he worked in highly regulated environments. Much of time this meant the FDA regulations for pharmaceuticals. He is very familiar with 21 CFR 210 and 211 as well as the ICH guidance for API's (Q7A). Much of his career has been spent interpreting and following these regulations and guidance documents. Much of expert's time developing advanced epoxy composites was focused on the highly demanding Aerospace requirements that varied from commercial aviation to space vehicles, satellites, and missiles at all of the major aerospace companies.

Expert has spent over 15 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked my way up into R&D management. Most of these involved epoxy resins. He worked extensively formulating 2 part curing epoxy adhesives as well as one part adhesive films and composite materials.

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autoclave composite processing

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bioprocess engineering

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carbon composite

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carbon fiber

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composite material mechanical property

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Current Good Manufacturing Practice

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epoxy matrix composite

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epoxy resin

Working on both sides of epoxy chemistry: the developer and the user, he needed to be very familiar with how these materials are used. This meant formulation for specific final properties such as high temperature performance or toughness or on the user end selecting the appropriate epoxy material that would meet the demanding specification requirements. Thermal properties were often on the top of the list for most applications and he developed and selected the appropriate epoxy resin for the thermal environment in which it would be used.

At times the viscoelastic properties of the epoxies were of critical importance to the end users. As a result, he had to take this into consideration when developing new materials. This resulted in becoming very familiar with the use of rheology for determining the viscoelastic properties of epoxy materials. Working a Lockheed martin as the user he also had to be aware of the viscoelastic materials from a cure and use perspective.

A large part of his career was spent in process development and QA working for medical device companies. These devices included mechanical, chemical synthesis, hardware, software, and biological materials. Expert has extensive experience with product development and QA of medical devices (21 CFR 810). As part of QA working for medical device companies it was expert's job to ensure that risk or hazard analysis was performed during the product development. This at times included FMEA as well as other techniques to assess that a safe and effective product was being developed.

Expert has served in QA positions where he was responsible for the final inspection of medical devices in the course of product development. This inspection was essentially a validation that the device is meeting the design out put from the detailed DHF. He served in QA at two very different medical device companies. In both companies he was a member of QA. He knew that when a product was released he was assuring the FDA and other regulatory authorities that the device was safe and effective. Working closely with RA he was aware of the liabilities as prescribed by the FDA should there be a problem with the device.

He has been involved in medical devices at two different companies. In both he served in QA role working very closely with QC during the manufacturing process. This meant determining AQLs for various parameters as well as investigating OOS or OOT conditions. Expert was intimately involved in all aspects of their testing.

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epoxy resin thermal property

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epoxy resin viscoelastic property

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medical device design

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medical device hazard analysis

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medical device inspection

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medical device safety

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medical device manufacturing quality control

Expert has been involved in medical devices at two different companies. In both he served in QA role working very closely with the various technical groups involved in the product development. As QA, Expert was responsible for the DHF and ensuring that the design output equals the design input. This also involved resolving problems that might arise during the development as well as conducting the risk analysis.

He worked in QA in a small molecule Pharma company. In this role he managed the final disposition of API lots. Lead and document problem investigations, deviations, and complaints. Managed and lead API validation for GMP/GLP operations, including equipment and facility qualification and supporting computer systems (21CFR part 11). Provided QA/technical oversight to API release, aseptic processing, validation, investigations, deviations, and complaints at contract manufacturing sites (CMO's). Responsible for review of the CMC section of regulatory filings. Worked with Regulatory for IND/NDA's, updates, and reportable process changes for worldwide compliance. Developed and enhanced validation systems and documentation standards/templates, train functional departments. Working closely with QC develops and validates new test methods and stability protocols. Key team member/lead in FDA/regulatory inspections (internal and CMO's). Supervise professional staff. Assured GMP/GLP compliance at contract sites for API manufacturing. Managed and perform internal and external GMP/GLP audits. Planned and direct QA activities in support of API clinical and commercial manufacturing including GCP support. He has completed validation of new pilot manufacturing facility ahead of schedule. Worked closely with an API contractor to improve their quality system resulting in reduced OOS, and OOT conditions and deviations.

Expert is certified and an ASQ (American Society for Quality) quality auditor. As such he has conducted several hundred first and second party quality audits.

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medical device product development

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pharmaceutical quality assurance

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quality auditing


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California;  San Francisco, California;  Sacramento, California;  Oakland, California;  Stockton, California;  Fremont, California;  Modesto, California;  Salinas, California;  Santa Rosa, California;  and Hayward, California.

Often requested
with this expert:

Adhesive Consulting, Formulating, & Research in Structural,...
Adhesives and Sealants
Adhesives, Encapsulation: Electrical/ Electronic, and...
Adhesive Formulation

Education:
Year   Degree   Subject   Institution  
1979   Ph.D   Organic Chemistry   University of Washington  
1974   AB   Chemistry, Chemical Engr.   Cornell University  
2005   Certification   Regulatory Affairs   San Diego State University  
2003   Certified Quality Auditor   Quality Assurance   American Society for Quality  

Work History:
Years   Employer   Department   Title   Responsibilities

2005 to

 

(Undisclosed)

 

QA, Chemical manufacturing

 

Sr. manager

 

Manage final disposition of API Assure GMP compliance at contract sites for API manufacturing. Manage and perform internal and external GMP audits. Plan and direct QA activities in support of API clinical and commercial manufacturing. Mlots. lots. Lead and document problem investigations, deviations and complaints. Manage and lead API validation for GMP operations at GFC, including equipment and facility qualification and supporting computer systems. Develop and enhance validation systems and documentation standards/templates, train functional departments. Provide QA oversight to validation at contract sites. Key team member/lead in FDA/regulatory inspections (internal and external). Supervise professional staff.

1999 to 2005

 

Affymetrix

 

Manufacturing Development, QA

 

manager

 

Quality: Represented Quality on new and sustaining project teams to assure QSR/cGMP/ISO compliance for medical devices and assisted in the development and implementation of validation test protocols, test methods, specifications, etc. In a QSR/ISO environment set the strategic direction for managing critical materials suppliers including new supplier qualifications and the recertification of existing suppliers. Lead supplier audit teams, the Supplier Review Board, and managed corrective and preventative actions (CAPA). Working closely with development, manufacturing, and suppliers, established criteria for qualification of new materials and processes which in many instances were treated as API's. Process: Lead project teams for support of new product/process development and improvements for existing manufacturing processes. Moved products from R&D small-scale non-optimal processes to the final production scale equipment and processes. Characterized various parts of the manufacturing process to develop and validate robust processes for consistent high yields. Developed materials specifications focused on the critical needs of the manufacturing process.

1989 to 1999

 

Lockheed Martin

 

R&D, Missiles & Space

 

Manager

 

Manager of Chemicals Support Group & Materials & Processes Program Manager. Materials & Processes Program Manager for a major developmental program. Responsible for supply base management including Quality/Process audits and process validation. Technical management for materials development, process development & validation support (polymers, films, adhesives, coatings, paints, potting compounds, gels, plastics, & hazardous materials and chemicals), chemical and physical characterization, materials selection and problem resolution, and vendor and subcontractor interactions. Promoted from Staff R&D Scientist conducting research in polymer formulation, adhesion and surface chemistry, adhesives, coatings/films for specialized applications, fibers, and resins. Developed/synthesized materials and processing techniques (coating, extrusion, injection molding, compression molding, RTM, thin films, etc.) and transition programs into production.

1988 to 1989

 

Advanced Dielectrics, Inc

 


 

Director

 

Technical Director directing the activities of Quality Assurance/Quality Control, Process Engineering, Analytical Chemistry, and R&D (web coating). Supported manufacturing and external customers for CAPA (Corrective and Preventative Actions) and complaint handling. Responsible for the research & process development of film adhesives and composite laminates for electronic circuit boards.

1988 to 1982

 

Dexter Corporation

 

Hysol Division

 

manager

 

Group Manager of Advanced Composites R & D Group. Conducted formulation and process development of thermoset and pressure sensitive adhesives and matrix resins and thermoplastic extrusion & injection molding. Synthesized new specialized adhesives and curing agents, conducted research in surface chemistry and adhesion science. Investigated new coupling agents, adhesion promoters and techniques (i.e. CVD, plasma). Performed chemical characterization and analytical process development. Promoted from Senior Chemist in the Polymer Technology Group to Project Leader and then to Group Manager.

1980 to 1982

 

Boeing Commercial Airplane Company

 


 

engr.

 

Senior Materials Engineer working on high performance adhesives, matrix resins and high strength fibers for advanced composites. Developed materials and process specifications. Provided program support and support for automated processing of composites.

1979 to 1980

 

Bio-Rad Laboratories

 


 

Chemist

 

Research Chemist developing amphoteric oligomers and conducting polymer synthesis/modification for the bio-medical market.


Career Accomplishments:
Associations/Societies

American Society for Quality; American Chemical Society; The Society for the Advancement of Materials and Process Engineering; The Society of Plastics Engineers. Board member of Advanced Polymer Composites Division

Licenses/Certifications

Certified ASQ Quality Auditor. Regulatory Affairs Certification from San Diego State University.


Publications:
Publications and Patents Summary

Expert has many publications and patents within his areas of expertise.


Government Experience:
Years   Agency   Role   Description
1988 to 1999   Army, NASA   contractor   Materials & Processes Program Manager for a major developmental program. Technical lead for contractor interactions and responsible for supply base management including Quality/Process audits and process validation. Technical management for materials development, process development & validation support (polymers, films, adhesives, coatings, paints, potting compounds, gels, plastics, & hazardous materials and chemicals), chemical and physical characterization, materials selection and problem resolution, and vendor/contractor interactions. Promoted from Staff R&D Scientist conducting research in polymer formulation, adhesion and surface chemistry, adhesives, coatings/films for specialized applications, fibers, and resins. Developed/synthesized materials and processing techniques (coating, extrusion, injection molding, compression molding, RTM, thin films, etc.) and transition programs into production.

Consulting Services:
Selected Consulting Examples:
  • Expert has experience with process development. He has performed stability testing and can help with developing the appropriate documentation for the process. Expert can provide manufacturing support for existing and developing processes. He also can assist with adhesives design and testing.
  • Expert has been involved in numerous consulting jobs that have involved developing and/or selecting the proper adhesive to meet very demanding applications in the areas of medical devices, aerospace, and other commercial applications.
Recent Client Requests:
  • Expert in epoxy tubesheets- membrane products.
  • Expert in low Cl electronic grade Epoxy
  • Packaging epoxy expert for consulting on appropriate testing methodologies and possible epoxy improvements.
  • Expert in PFMEA applied to chemical processes.
  • Aerospace chemist needed for consulting regarding 2 Part epoxy adhesive for aerospace Use.
  • Epoxy expert needed for consulting regarding an epoxy qualification plan.
  • Expert for consulting on Polyethylene file for medical device application.
  • Expert in cyanoacrylates and polyurethanes for consulting on medical device use issues.
  • Epoxy chemistry expert for consulting and class instruction on changes in the formulations of the epoxy systems.
  • Microelectronic adhesive expert for consulting on medical device adhesive application issues.
  • Expert for consulting on Reduction of Yield loss due to poor adhesion of hot melt to textile.
  • Expert in pressure sensitive adhesives for consulting on PSA understanding for adhering polymeric, microstructured film to glass.
  • Expert in sythetic chemisty testing for consulting on Sythetic Organic Chemistry.
  • Medical device packaging expert for consulting on blister packaging of contact lenses.
  • Medical adhesive tape expert for consulting on Selection of adhesive tape for medical 72 hour use.
  • Expert in chemistry for consulting on epoxy product formulation/breakdown.
  • Expert in custom formulation of adhesive for consulting on desired custom adhesive.
  • Adhesive expert needed for consulting on powder adhesive.
  • Expert in pharmaceutical shelf life testing for consulting on environmental control testing.
  • Expert in chemistry for consulting on designing slime made from Guar Gum and Borax powder.
  • ELAP laboratory accreditation expert for consulting on lab accreditation in CA for 8260B.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
Expert wittness expereince in the areas of adhesives and fiber reinforced laminates. This includes formulation of adhesive resins (epoxy, bismaleimide, polyimide, etc.) and laminate/prepreg formulations.
Recent Litigation Client Requests:
  • Expert in Potted connectors.
  • Expert in PCB laminate for testimony on a patent litigation case.
  • Epoxy flooring expert for consulting on product selection.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Market Research:
Special skills in the formulation and use of adhesives and other resins for the medical device industry.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Training/Seminars

Systems Engineering/Project Management, Facilitating Creative Thinking, and misc. technical management, business accounting, and personnel development. Technical: Supply Base Management and Design of Experiment (DOE). Quality: Complying with cGMP and GMP Requirements, Quality Auditor, Regulatory Compliance for Biologics, ISO 9000:2000 & ISO 13485, Risk Management/FMEA, Improving Inspection Effectiveness

Supplier and Vendor Location and Selection

Expert has worked on vendor selection in most of his past job experiences. As an ASQ Certified Quality Auditor, Expert has conducted over 300 audits to FDA regulations, ICH Guidlines, and ISO Standards.

Other Skills and Services

Expert has taught organic chemistry and biochemistry at the Community College and University level as well as classes on adhesion science and bonding, surface science, adhesive and resin formulation.


 

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