Manufacturing Expert Witnesses

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Manufacturing expert witness candidates are typically licensed professional engineers with extensive experience and expertise in mechanical engineering, industrial engineering, product design, and/or the manufacturing process. To support either a plaintiff or defendant, Cahn Litigation Services is frequently called upon by law firms to locate an expert witness that can support issues involving manufacturing.

Cahn Litigation Services has completed numerous searches for an expert witness in the manufacturing arena, providing candidates for each case to the specifications provided by the attorney in charge. Whether it’s for a patent case or for pre-litigation reverse engineering work, Cahn Litigation Services has the experience required to turn the search around quickly. The firm provides the right balance of expertise and testimony to provide the perfect expert for the job at hand.

An expert in manufacturing could provide expertise in intellectual property matters, including patent infringement or a trade secret dispute. It could be an Inter Partes Review (IPR) in the PTAB (where the only expert testimony is through a deposition), or a patent case or proceeding in the International Trade Commission (ITC). An engineer with specific knowledge in manufacturing might provide expert opinion in a matter such as a product liability case, or provide testimony in a personal injury case.

Litigation support could include expert witness services such as an expert report, failure analysis, accident reconstruction, forensic analysis, and expert witness testimony. In a high-profile case, or litigation involving a significant financial stake, a law firm may request a mechanical engineer with specialized knowledge in manufacturing that has prior experience as a testifying expert. A manufacturing expert needs to not only have expertise, but must also possess the ability to provide expert testimony in such a manner that a jury and judge can understand the evidence. In addition, clients may seek a subject matter expert for pre-litigation consulting work.

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Manufacturing Expert Witness - Sample Bios

Please Note: All Cahn Litigation expert witness searches are customized to attorneys' precise specifications and preferences. Attorneys are encouraged to discuss search parameters with a Cahn search specialist.

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The below expert witness bios represent a small fraction of those Manufacturing experts known by Cahn Litigation Services. These bios are provided to give attorneys a sense of the Manufacturing landscape.

Expert Witness #226432

This expert holds a BS and MS in Mechanical Engineering and is a Registered Professional Engineer (PE). Specializing in design engineering, development, and manufacturing, this expert brings to the table many years of industrial experience. This expert's prior litigation experience includes arbitrations, depositions, hearings (Daubert, Markman, and evidentiary), and trials (bench and jury).

This expert has designed and developed -- or assisted in litigation of -- products specifically for ophthalmic, uterine, prostate, and dental surgery. Related products include instruments and devices for laparoscopy, colonoscopy, vacuum therapy for the skin, razors, cardiac stents, cardiac pacemakers, and auto-injectors ("epi-pens"). This expert has designed or supervised the design of hundreds of products and prepared or reviewed thousands of design and manufacturing drawings. This expert has carried out product-development projects and managed a machine shop and a complete manufacturing department. Further, this expert has taught college courses in industrial design.

This expert has served as expert witness in more than 100 litigation cases, mostly patent-related. This expert has testified at deposition more than 30 times and at hearing or trial, including jury trial, more than 15 times. This expert has also supported several IPRs.

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Expert Witness #236118

This expert is well-published, having authored five books on supply chain as well as an Amazon Best-Seller. This expert has significant expert witness experience in global manufacturing, import/export trade compliance, Chinese products, supply chain and outsourcing and has written numerous expert reports and testified in arbitrations and trials. This expert has been a frequent presenter at industry conferences and has taught at colleges and universities.

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Expert Witness #246983

This expert earned a PhD in Chemical Engineering from a prestigious university and has devoted much of a career to reducing variation in manufacturing quality and optimizing production. This expert is well-published, having authored or co-authored over forty publications in manufacturing technology, and is author to six publications related to the Chemical Vapor Deposition of polysilicon. This expert is also author of 77 patents, including two specifically related to polysilicon. As Director of Automation Applications, this expert helped a major semiconductor company develop and implement advanced control algorithms in manufacturing, including the design, build and application of control systems. Now a consultant, this expert has been engaged on matters related to IP portfolio assessment and has provided expert witness support, though has not yet been deposed or provided testimony.

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Expert Witness #248180

This expert holds a PhD in Precision & Microsystems Engineering, Mechatronic System Design and serves as Assistant Professor of Mechanical Engineering and of Optics. Specializing in machine design, instrumentation and metrology, particularly surrounding opto-mechanical machines/instruments and machines for manufacturing, this expert is published widely on surround custom instruments & systems that have been built and qualified for research purposes. Additionally, this expert teaches elements of machine design for manufacturing. In addition to academic experience, this expert has worked in the industry for an optics manufacturing equipment company. This expert has served as an expert in litigation.

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Expert Witness #258779

This expert is the Chief Technical Officer of a highly successful materials engineering and manufacturing firm specializing in flexible body armor technologies as well as other related items. This expert began a design/manufacturing career with plastic products. This expert’s firm performs design engineering to develop products, create turn-key production lines, or manufacture, including an advanced materials systems for weapon components including polymer and ceramic. This expert’s research extends from armor and munitions to Composite Reinforced Ceramic Technology (CRCT) machinegun barrels.  Materials utilized include advanced engineering ceramics, self-reinforced thermoplastics, thermoset resins, and advanced composite structures.

This expert created a start-up plastics manufacturing company that evolved into a leading regional injection molding, engineering and mold-making company. Manufacturing technologies included: design engineering, toolmaking, injection molding, thermoset molding, thermoset composite forming, thermoplastic composite fabrication, assembly and packaging. This expert invented and led the development of novel patent-pending mold-making technologies, and added a "paperless" engineering and toolmaking protocol that integrated 3DCAD/CAE/CAM with Quality Assurance and Marketing. This helped the company to earn a high vendor rating and excellent "LEAN" percentage from U.S. government prime contractors. This start-up  served a major OEM manufacturer of grips, stocks and other components for US and European firearms manufacturers.

This expert’s expertise goes well beyond design engineering and manufacturing:

  • an active designer, licensed firearms dealer, owner/operator of a retail gun store, licensed firearms manufacturer, registered armaments exporter and writer
  • an inventor of 11 issued patents including several having to do with plastic components for armaments.
    • researched, written and filed patents and participated in the patent examination process.
    • is familiar with the MPEP, and has visited the USPTO to personally interact with examiners.
    • has utility patents, and filed a design patent application for ergonomic firearm grips
    • was retained during an examination to prepare an Expert Declaration regarding description of technology and lexicon used for a “Section 102” rejection.
    • was firearms training officer for a Highway Patrol department which included instructing handgun, shotgun and rifle. This expert performed armorer duties for police, sheriff, and state agencies, as well as federal agencies located. This included building specialized weapons, such as sniper rifles, for law enforcement use.
    • crime scene reconstruction and analysis of shooting incidents. This expert provides expert witness consulting and testimony for major felony cases.

In addition to prior work as an expert in criminal matters, this expert has served as a subject matter expert for patent, Trade Dress, and Trademark matters. This expert has prepared expert declarations on Post-Grant Review, and worked with attorneys on Ex Parte Reexamination and Inter Partes Review.

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Expert Witness #261242

This expert is the principal design engineer in an eponymous consulting firm dealing with design, usually from an intellectual property standpoint. This expert has designed many household appliances and their accessories. This expert has extensive experience working with Chinese manufacturers to ensure the correct production of new or redesigned products. This includes traveling to China to meet with executive general managers and production engineers of over 30 Chinese manufacturing plants. This expert has analyzed manufacturing capabilities and ways to align their capabilities with the designs, or vice-versa. This expert has experience reviewing the first test production pieces, providing feedback of changes to the tools before full production begins.

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Expert Witness #261650

This expert has a Master's degree in Biomedical Engineering, and another in Engineering Management. This expert currently leads a medical device design and consulting firm and provides services to corporations and law firms as a manufacturing consultant and expert witness. Before founding this company, this expert supervised Manufacturing and Research and Development for a medical device manufacturer and had responsibility for Product Development at another. This expert is well acquainted with manufacturing and deviation tolerances, and other characteristics of machining and the manufacturing process. This expert boasts over 60 medical device (US) patents. This expert is well-published and serves as an adjunct professor at a University. As an expert witness this expert has provided services in patent infringement litigations, IPR post-grant proceedings and an array of products and injury matters involving medical devices. This expert has specific experience in validity, infringement claim construction and Markman hearings.

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Expert Witness #267522

This expert has many years of microbiology experience including practical proficiencies in pharmaceutical, biotech, medical device research and development, manufacturing quality and business development.  This expert also brings to the table practical experience as a microbiology expert witness in patent litigation and product liability cases. This expert has successfully served as a microbiology expert witness on numerous cases, representing branded and generic drug companies, corporations and individuals, plaintiffs and defendants. This expert has supported clients during fact finding/expert discovery and claim construction in addition to providing consultation, patent review, expert opinion, deposition and trial testimony. This expert has also provided technical guidance to counsel in preparation of taking depositions.

This expert has significant education, training, skill sets and experience, and has provided legal support as a consultant and expert witness in many areas, including:

  • Pharmaceutical microbiology
  • Sterility assurance
  • Good Manufacturing Practices (GMPs)
  • FDA regulatory compliance
  • Contamination control
  • Sterilization
  • Preservative and antimicrobial effectiveness
  • Compounding pharmacy microbiology
  • United States Pharmacopoeia (USP) testing
  • Laboratory operations
  • Ophthalmic formulations and contact lens care

This expert’s capabilities span a wide range of applications and functions, including, but not limited to:

  • Manufacturing
    • Sterility assurance and aseptic processing
    • cGMP compliance
    • Investigations of microbial excursions, presence of objectionable organisms and out-of specification findings
    • Contamination control and bioburden reduction strategies for sterile and non-sterile fill-finish facilities
    • Manufacturing isolator and RABS design, cycle development and microbiological validation
    • Process development
    • Manufacturing facility design and qualification
    • Process Analytical Technology (PAT)
    • Environmental monitoring (sterile and nonsterile)
    • Fermentation, recovery and purification microbiological control (API, bulk drug)
    • Process water monitoring and maintenance
    • Disinfection and sterilization
    • Cleaning validation
    • Audit readiness
    • Rapid microbiological method (RMM) validation and implementation
  • Microbiology Laboratory
    • Laboratory audits, optimization and management
    • Laboratory design, qualification, optimization and automation
    • Sterility test isolator design, cycle development and microbiological validation
    • cGMP compliance
    • Microbiology method suitability testing, including the harmonized Sterility Test and Microbial Limits Test, Antimicrobial Effectiveness testing, USP 1223 and1227
    • Sterility testing (harmonized)
    • Antimicrobial and preservative effectiveness testing
    • Environmental monitoring
    • Pharmaceutical-grade water analysis
    • Bioburden and microbiological examination of nonsterile products (harmonized Microbial Limits Test)
    • Disinfectant effectiveness validation
    • Microbial identification strategies and instrument/method validation, including gene sequencing and MALDI
    • Endotoxin analysis and method validation
    • SOP and protocol development
    • Method validation and technology transfer
    • Pharmacopoeia (e.g., USP, Ph. Eur., JP) interpretation and compliance
    • Risk assessments (e.g., objectionable organisms, microbial data deviation, bioburden excursions)
    • Documentation and data management
    • Rapid microbiological method (RMM) validation and implementation
  • Quality, Regulatory and Product Development
  • Failure investigations and root cause analysis
  • Microbial data deviation investigations
  • Audit response (e.g., FDA 483, warning letters, consent decree)
  • Regulatory submission support associated with microbiological processes (e.g., NDA, ANDA, IND, BLA, marketing authorization)
  • Pharmacopoeia (e.g., USP, Ph. Eur., JP) compliance
  • Contact lens care and ophthalmic formulation development, manufacturing, stability testing and product release
  • USP 797 compliance, pharmaceutical compounding of sterile preparations (compounding pharmacies)

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