Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Professional with solid technical and compliance knowledge and skilled in product development of Class I, II, and III medical devices. Over 14 years of experience working with global medical device and combination product manufacturers.  Background in In Vitro diagnostics, combination products (e.g., drug-eluding stents), balloon and self-expanding stents, balloon catheters, drug delivery catheters, wire guides, needles, and embolic protection devices.

CORE COMPETENCIES

  • Research & Development/Product Development
  • Project Management/Project Leadership
  • Design Controls/Design History Files (DHFs)
  • Change Management/Change Controls
  • Device Master Records (DMRs)
  • Quality System Development/Support
  • Risk Management/FMEA/Hazards
  • Analysis Procedural Development/Audits
  • Process Development/Process Controls
  • Corrective and Preventative Actions
  • Process Validations (IQ/OQ/PQ)
  • 21 CFR Part 820/Part 210/Part 211
  • Operating Procedures/Work Instructions
  • ISO 9000/ISO 13485/ISO 14971
  • Molding/Injection/Insert/Over Molding
  • Training/Training Materials/Assessments
  • Extrusion Tool design/3D Modeling
  • Process Improvement/Methods/Tools

SELECTED ACCOMPLISHMENTS

  • Provided project leadership for Risk Management Process and Risk Management File under warning letter remediation effort including the following:
    • Led Team of Quality Assurance Engineers, Quality Systems Engineers, Technical Writers and Training Designers to create, release and implemented quantitative risk management process
    • Project Management and mentoring Risk Team effecting the establishment of Risk Management File deliverables (e.g., design FMEAs, process FMEAs and use FMEAs) compliant to risk management process and EN 14971:2012
  • Provided project leadership for Design History File remediation including the following:
    • Research and acquisition of DHF support documentation
      • Acquired/authored, approved, and released documents associated with:
        • Design Input and Output Requirements
        • Traceability Matrices
        • Verification and Validation protocols and reports
    • Review/evaluate criticality analyses, risk analyses , preliminary hazard analyses and authored Risk Management Reports for remediated combination products
  • Provided risk management oversight for global medical device manufacturer of In Vitro diagnostic assays and assay instrument platforms under warning letter remediation effort, including the following activities:
    • Provided 483 remediation support activities in the area of risk management.
      • Mentored project teams during design change and risk documentation development following implementation of new risk management process.
      • Reviewed, red-lined, and approved over a thousand risk documents including design, process, and application FMEAs, risk assessments, risk management plans/reviews/reports, and system risk assessments in accordance with FDA obligated interim controls.
      • Authored training materials/assessment tests and conducted training on ISO 14971 and FMEA concept fundamentals and company’s new risk management process for over 40 engineers, quality assurance personnel, and management.
      • Named Global 3rd Party consultant on risk management, leading effort and setting FDA obligated interim controls.
      • Trained, mentored and certified internal resources at multiple global sites as Risk Managers/Specialists.
    • Provided 483 remediation support activities in the area of pre-market notification
      • Performed process mapping of design change and pre-market notification processes used to modify pre-market notification procedures.
      • Reviewed, red-lined, and approved new set of pre-market notification procedures and decision trees compliant to 21 CFR Part 807 Subpart E/809/814/860/862/864/866.
      • Reviewed, red-lined and approved training materials and assessment tests.
  • Managed various project activities for medical device manufacturer of products in critical care, diagnostics and interventional radiology, peripheral intervention, endoscopy and surgery, including the following activities:
    • Managed multiple project teams delivering implantable products (drug-eluding stent and balloon expandable stent) to clinical trial.
    • Performed research, design, and development of medical devices and their associated manufacturing processes including scale up to production.
    • Authored DHF and risk management files for various medical devices, such as a wire guide hemostasis device, catheter fixation device, stent delivery system, blunt force trauma device, and covered endovascular stent (user requirements, design input documents, multiple design output documents, drawings, etc.)
    • Performed/coordinated prototyping, characterization studies, biocompatibility studies, animal studies, verification and validation, and associated histology activities for drug-eluting stent delivery systems, blunt force trauma devices, and covered stent delivery systems.
    • Performed extensive research in the field of super-elastic metals (Nitinol), including tensile testing, differential scanning calorimetry (DSC), dynamic mechanical analysis (DMA), x-ray diffraction experiments, data acquisition, and analysis leading to innovative stent designs.
    • Co-authored formal design control and risk management procedures compliant to 21 CFR Part 820, ISO 13485, ISO 14971:2007 and EN ISO 14971:2012.
    • Audited and coordinated remediation of drug-eluting stent DHF.
    • Awarded 19 US patents and 1 international patent.
    • Authored engineer internship and engineer training programs.
  • Provided quality management system development support for medical device start-up company of new In Vitro diagnostic technology and instrument platform, including the following activities:
    • Developed risk management process compliant to ISO14971:2007 and EN ISO14971:2012 revolved around start-up company’s line of IVD products.
    • Authored multiple risk management procedures, work instructions, and risk documentation templates facilitating implementation of risk management process.
  • Provided industry training, including the following:
    • Risk management training at OrthoTec 2013, Warsaw Indiana to representatives from OEMS (such as Zimmer, Spinal Simplicity & DePuy) with a few suppliers (such as Arthrex Manufacturing, Plasticomp, and McMaster-Carr) with a mix of job titles ranging from director, QA/QC, and engineering titles.

PROFESSIONAL EXPERIENCE

  • Boston Scientific, Project Lead, Warning Letter Risk Management File Remediation – 1/2016 to 2/2017
  • Boston Scientific, Project Lead, Quantitative Risk Management Process Development – 4/2015 to 1/2016
  • Johnson & Johnson®, Project Lead, Design History File Remediation – 11/2013 to 7/2015
  • Rapid Diagnostek®, Risk Management consultant – 12/2012 to 5/2013
  • TDC Medical, Inc, Product Development consultant – 8/2012 to 8/2012
  • Beckman Coulter, Risk Management 3rd party consultant – 3/2011 to 9/2013
  • Cook Medical, Senior Development Engr. and Development Engr., Bloomington, IN – 8/2002 to 3/2011
  • Vermont Yankee Nuclear Power Corporation, Senior Regulatory Compliance Engineer and Shift Technical Advisor, Vernon, VT – 11/1997 to 8/2002
  • Department of Defense, Shift Test Engineer and Nuclear Engineer, Portmouth, NH – 10/1987 to 11/1997

EDUCATION

  • Bachelor of Science, Nuclear Engineering, UMASS at Lowell, Lowell Massachusetts – 9/79 to 5/84
  • Coursework in Electrophysiology and Biomedical Fluid Mechanics, Rose-Hulman Institute of Technology, Terre Haute, Indiana – 9/06 to 5/07

CERTIFICATION

  • Shift Test Engineer Certification, Portsmouth Naval Shipyard – 1992 to 1997
  • Shift Technical Advisor Certification – 1998 to 2002
  • Licensed Operator Certification – 1998 to 2002

TRAINING

  • Root Cause Analysis, Vermont Yankee Nuclear Power Corporation – 1997
  • Facilitating with Ease, Participative Dynamics – 1997
  • Total Quality Management, Conway Quality Systems – 12/00
  • Conflict Management, Conway Quality Systems – 12/00
  • Supervisory Training, Conway Quality Systems – 12/00
  • Human Performance, Vermont Yankee Nuclear Power Corporation – 1/01
  • ISO 13485
  • ISO 14971
  • Root Cause Analysis, Weaver Consulting – 5/05

AFFILIATIONS

  • ASME – American Society of Mechanical Engineers (Member # 000008104085) – 08/03 to Present