James Madenjian


Professional with over 20 years of experience in design engineering, project management, tooling engineering, plastics and polymer engineering, and manufacturing engineering. Highly credentialed with expertise in medical device and drug manufacturing industries. Background in drug delivery balloon catheter, disposable catheter, endoscopic sheath, laparoscopic, shunt, embolic, cardiac probe, RF ablation, dissection, bioabsorbable polymer, and endosurgical devices, custom injection molded device components, and elastomeric, composite, and rubber materials.



  • Product Development/Design Controls Project Management
  • Specifications/Test Methods Process Validations (IQ/OQ/PQ)
  • Tool Design and Validation Statistical Process Control (SPC)
  • Failure Mode Effects Analysis (FMEA) Kaizen Techniques
  • Design for Manufacture and Assembly (DFMA) 510K Submittals
  • Design History Files (DHFs) 21 CFR Part 820/Good Manufacturing Practices
  • Design Reviews ISO 9001/ISO 13485/ISO14971


  • Led technical activities for manufacturer of balloon catheters, including:
    • Conducted research and development for high pressure controlled drug delivery catheter
    • Submitted proposal for Small Business Innovation Research (SBIR) program for funding
  • Facilitated tooling activities for contract manufacturer of finished assemblies, subassemblies, and precision components for medical device manufacturers, including:
    • Designed and built tooling for plastic medical device components
    • Managed validations of 40 medical device components for customers, such as Datascope, Mini-Lab, Covidien, Suri-Quest, Chrysalis Labs, and Discovery Labs
  • Managed projects for leading medical device manufacturer specializing in efficiency and infection control solutions for flexible endoscopy, including:
    • Prepared proposal to develop low cost disposable endoscopic sheath
    • Identified materials, completed design, and developed process for fully automated manufacturer of disposable parts
  • Managed project activities for biopharmaceutical manufacturer of innovative, targeted therapies in oncology, including:
    • Coordinated Phase II and Phase III development of BPH disposable catheter system
    • Implemented process controls and training for all manufacturing processes
    • Completed 510K submission resulting in FDA approval
  • Managed design and development tasks for contract manufacturer, including:
    • Designed and built tooling for plastic medical device components
    • Validated all tooling for St. Jude Medical, Vascular Architects, United States Surgical Corp., BSC, and Neothermia Medical
  • Led medical device development and OEM group for manufacturer, including:
    • Completed Design History Files (DHFs) for laparoscopic devices, shunts, embolic devices, cardiac probes, RF ablation, and dissection devices
    • Conducted Failure Mode Effect Analysis (FMEA) with cross-functional teams
    • Led design reviews and associated meetings tasks
    • Developed production processes and conducted process capability studies to support IQ, OQ, and PQ validation work
    • Coordinated design and development efforts with medical device manufacturers, such as Boston Scientific Corp., Scion Medical, GMP, Seedling Enterprises, and TissueLink
  • Facilitated design activities for custom injection molding manufacturer of plastic components for healthcare industry, including:
    • Managed15 external customers, including tasks related to design, tooling, assembly, and transfer to manufacturing
    • Coordinated design, build, and transfer of more than $2 MM in tooling to manufacturing
    • Developed all molding processes and trained staff accordingly
    • Managed tool room, pad printing, and all secondary operations, as required
    • Implemented Kaizen process for molding operations
    • Established SPC for all new tools being transferred to production
  • Supported engineering activities for medical device manufacturer of surgical sutures and other wound closure products, including:
    • Developed tooling and injection molding technology for proprietary bioabsorbable polymers and liquid crystal polymers (LCPs) for laparoscopic devices
    • Implemented procedures and work instructions for compliance with ISO 9000
  • Completed project tasks for manufacturer of polymer materials, including:
    • Developed specifications for all plastic, elastomeric, composite, and rubber materials
    • Supported new product designs, tooling, and testing
    • Expanded polymer materials support group from one person to four people
    • Started in-house molding at three facilities, as well as implementation of prototype capabilities for sampling, with capital expenditures over $1MM
    • Developed and started-up new disposable surgical stapler
    • Developed composite “U-joints” and steering assemblies


  • J.M. Engineering Associates, Engineering Consultant (Marshfield, MA) – 1997 to Present
  • Clients and assignments include:
  • Medi-Solve/Medi-Balloon, Principal Investigator
  • Lacey Manufacturing, Tooling Engineer
  • Vision Sciences, Project Manager
  • Celsion Corp., Project Manager
  • Medsource, Tenax Division, Project Manager
  • Medsource, ACT Division, Project Manager
  • ACT Medical, Project Manager
  • ACT Medical, Project Manager
  • Boston Scientific Corp., Plastics Engineer
  • Tenax Corp, Project Manager, Advance Service Team (Danbury, CT) – 1995 to 1997
  • Davis & Geck, Sr. Mfg. Engineer, Advanced Engineering Endosurgery (Danbury, CT) – 1992 to 1995
  • The Torrington Co., Sr. Polymer Eng., Adv. Tech. Ctr., Materials Group (Torrington, CT) – 1985 to 1992
  • Texas Instruments, Inc., Mfg. Engineer, Molding (Attleboro, MA) – 1979 to 1985
  • Davol, Manufacturing Engineer (Cranston, RI) – 1978 to 1979
  • Smith-Corona, Materials Engineer, Technical Resource Laboratory (Cortland, NY) – 1976 to 1978
  • General Electric, Adv. Mfg. Engineer/Plastics Specialist/Sr. Project Eng. (Providence, RI) – 1972 to1976


  • Master of Science, Plastics Engineering, Lowell Technological Institute
  • Bachelor of Science, Plastics Engineering, Lowell Technological Institute


  • ISO 13485 Internal Auditor Certification, Central Connecticut State University (CCSU)
  • Project Management, Central Connecticut State University (CCSU)


  • Six Sigma Black Belt
  • General Electric Manufacturing Management Program
  • The Torrington Co., Total Quality Management Program
  • Davis & Geck Quality Education System
  • Tenax Quality Education System