Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Professional with solid technical background, skilled in product development, project management, and manufacturing engineering. Highly credentialed engineer with years of experience with top global medical device and drug manufacturers. Background in diagnostics, venous access safety related kits, anesthesia, dialysis access, catheter-based and antimicrobial technologies, pressure rated PICC devices, drug coated and uncoated peripheral stents, interventional radiology and cardiology products, stentgrafts, delivery systems, stage-gate process, sirolomus coated stents, bioabsorbable orthopedic and urologic implantable devices, implantable drug delivery systems, and ligament repair systems.

CORE COMPETENCIES

  • Product Development
  • Design Control/ Stage-Gate Processes
  • Design History Files (DHFs)
  • Device Master Records (DMRs)
  • Design Verification/Design Validation
  • In Vivo/In Vitro Test Methods
  • Hands-On Surgical Testing
  • Clinical Trials/Testing
  • Equipment Installations
  • Process Validations/Test Method Validations
  • Risk Analysis/FMEA/FMECA
  • Technical Files/IDEs/510Ks/PMAs
  • Project Management/Project Plans
  • Forecasts/Budgets
  • FDA 21 CFR Part 820
  • FDA 21 CFR Parts 210/211
  • ISO 13485/ISO 14971/ISO 11607
  • Procedural Development/Work Instructions
  • Change Management/Change Controls
  • Process Excellence/Cost Savings Initiatives

SELECTED ACCOMPLISHMENTS

  • ed technical activities for diagnostics manufacturer of reagents and other products, including:
    • Designed and developed diagnostic reagents in compliance with regulations
    • Supported development of dossiers, PMAs, Design History Files, etc.
  • Served as advisor to medical device and pharmaceutical companies providing project management, product development, quality system, and strategic planning, including:
    • Designed and developed medical devices in compliance with regulations
    • Supported development of combination drug device products
    • Provided strategic and tactical support during several class II recalls
    • Provided regulatory support for Technical Files, IDEs, 510K, and PMA submissions
    • Provided essential review and remediation to support transfer of medical device company into pharmaceutical company
    • Developed and implemented quality systems to meet the Quality System Regulations and European standards, such as ISO 11607, ISO 13485, and ISO 14971
    • Developed SOPs and specifications to complete Design History Files and Device Master Records
    • Audited quality systems and associated records for compliance identifying opportunities to strengthen and secure stability of quality systems platform
    • Developed remediation project plans, risk assessments, FMECA, forecasts, and budgets
    • Developed dashboards, reports, and presentations to keep management abreast of progress
  • Led product development activities for medical device manufacturer of balloons, catheters, and other custom extrusion products, including:
    • Facilitated all medical device design, development, and manufacturing with 100 associates and three U.S. locations
    • Supported start-ups and multi-national organizations with standalone and supplemental services, such as engineering, testing, project management, clinical supplies, clean room commercial manufacturing, and quality system development, execution, and remediation
    • Maintained over 50 active device projects which grew sales by over 20% and profitability by 125%
    • Supported systems to maintain compliance with ISO 13485 and ISO 14971
  • Coordinated product development activities for medical device manufacturer of broad range of venous access, regional anesthesia, and dialysis access catheter-based therapeutic products and antimicrobial technologies, including:
    • Managed budget of over $8 million, staff of six direct reports, and 30 indirect reports
    • Served as member of executive team responsible for portfolio and project management
    • Launched six pressure rated PICC devices and 24 venous access safety related kits, generating first year sales of over $25 million
    • Launched first pressure rated CVC catheter and Step Tip hemodialysis catheter which generated an additional $25 million in first year revenue
    • Implemented new quality system, associated SOP’s, documentation, and validations in response to FDA warning letter received prior to tenure
    • Identified and negotiated strategic partnerships and licensing arrangements
  • Directed engineering activities for medical device manufacturer of peripheral vascular and endovascular products, including:
    • Managed 50 % increase in staff during period of double-digit growth to introduce 40 new products, leading staff of six managers and 80 associates to coordinate product development across eleven companies in four countries
    • Served as member of executive committee responsible for guiding merger and acquisition activities while managing company’s launch of TaxolTM drug coated and uncoated peripheral stents, interventional radiology and cardiology products, Zenith TM  AAA stentgrafts, and delivery systems
    • Implemented stage-gate process with marketing to ensure balanced project portfolio
    • Modified design control procedures to incorporate ISO 13485 and ISO 14971
    • Worked in partnership with business development to perform due diligence on licensing and acquisition opportunities
    • Assessed procedures and processes to evaluate change and cost reduction measures with first year reductions exceeding $2 million
  • Managed product launch activities for biomaterials manufacturer of Sirolomus coated stents, bioabsorbable orthopedic and urologic implantable devices, and other implantable drug delivery systems, including:
    • Identified new business opportunities, licensing, and acquisition candidates
    • Managed project portfolio and maintained steady flow of products to market
    • Partnered with operating companies to develop strategic plans and assess market potential for collaborative projects
    • Formed new company with development corporation and outside venture company based on underutilized technology
    • Completed pilot clinical trials and attracted second round funding partners
    • Implemented process excellence program for overall improvement
    • Developed and negotiated variety of legal agreements
    • Instituted healthcare compliance based on HIPPA and AMA guidelines and administered $2MM government matching fund grant
  • Led strategic planning and management group for biomaterials manufacturer of orthopedic products, including:
    • Managed project leaders in developing new materials and products that supported  medical device and diagnostics sector operating companies
    • Developed project plans, assigned and managed resources, and presented recommendations to senior management
    • Designed and implemented project selection and management process and implemented project planning and database software to enhance efficiency
    • Led development and launch of Rigid-fixTM anterior cruciate ligament repair system which exceed sales expectations in years two and three by 100%
  • Directed team focused on research and analysis of medical industry markets, competitors, and products for medical device manufacturer of access, biosurgery, endo, energy, gastric banding, gynecology, hernia, ligation, stapling, and wound closure products, including:
    • Managed one-on-one interviews with leading surgeons and medical personnel
    • Identified licensing and acquisition targets
    • Developed specific business plans/proposals
    • Summarized and presented findings to senior corporate management leading to efforts that resulted in three acquisitions and closing of numerous licensing deals
    • Managed new product implementation group for medical device manufacturer with responsibility for administration, planning, budget, and development of new medical devices and processes
    • Coordinated equipment procurement and installation, validation of processes and test methods, and transfers to manufacturing
    • Led three device development and product launch teams, including Lapra-TyTM suture clip
    • Served as member of corporate ISO and FDA Quality Systems steering committees
    • Coordinated in vivo and in vitro test methods and “hands-on” surgical testing
  • Facilitated engineering activities for custom molder and assembler of precision components, including:
    • Drove “turn-around” from six years of consecutive losses to profitability, thereby increasing value and marketability and attracting several potential buyers
    • Reorganized sales and marketing, engineering and quality assurance departments
    • Increased group dynamics and decreased response time to customers
    • Served as member of board of directors which negotiated new union contract
    • Identified and negotiated acquisition of tool and die company
    • Founded FDA registered medical manufacturing company

PROFESSIONAL EXPERIENCE

  • Independent Consultant (Flemington, NJ) – 2007 to Present
  • Vention Medical, Inc., Vice President Product Development (Marlborough, MA) – 2011 to 2012
  • Arrow International Inc., Sr. Dir. Global Critical Care Product Dev. (Reading, PA) – 2005 to 2007
  • Cook Incorporated, Director of Engineering (Bloomington, IN) – 2003 to 2005
  • J&J Ctr. for Biomaterials/Advanced Tech., Mgr., New Program Dev. (Somerville, NJ) – 2000 to 2003
  • J&J Corporate Biomaterials Center, Manager, Project Management (Somerville, NJ) – 1996 to 2000
  • Ethicon, Div. of Johnson & Johnson, Mgr. Strategic Planning/Bus. Dev. (Somerville, NJ) – 1994 to 1996
  • Ethicon, Inc., Div. of Johnson & Johnson, Principle Engineer (Somerville, NJ) – 1991 to 1994
  • JDI Technologies, Principal (Putnam, CT) – 1990 to 1991
  • Moldex, Inc., Vice President of Engineering (Putnam, CT) – 1987 to 1990
  • Moldex, Inc., Director of Engineering (Putnam, CT) – 1986 to 1987
  • Celanese Specialty Operations, Applications Engineer (Summit, NJ) – 1985 to 1986
  • Johnson & Johnson Baby Products Co., Plastics Packaging Coordinator (Skillman, NJ) – 1982 to 1985
  • Stromberg Carlson Corp., Manufacturing Engineer (Charlottesville, VA) – 1980 to 1982

EDUCATION

  • Master of Science, Plastics Engineering, University of Lowell (Lowell, MA) – 1986
  • Bachelor of Science, Plastics Engineering, University of Lowell (Lowell, MA) – 1980

AFFILIATIONS

  • Society of Plastics Engineers
  • Product Development Management Association

PATENTS

  • Awarded six issued U.S. Patents