Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Results-driven medical device professional with extensive background and experience in design controls, Risk Management, DHF preparation, audit, and remediation, project/program management, and product design/development for global medical device companies. Background in coated urological catheters, IV drug pumps and tubing sets, combo syringe-drug devices, vascular and obstetric catheters, safety syringes and pen needles, mechanical and electro-mechanical blood pressure monitoring devices, mechanical and electronic stethoscopes, laser ablation catheters and lasers, ex-vivo blood flow technology, mechanical heart valves, combination products and IVD equipment and reagent filling processes.

CORE COMPETENCIES

  • DHF Remediation
  • Risk Management/FMEA/FTA/Hazard Analysis
  • Design History Files
  • DHF Remediation/Gap Analysis
  • Design Controls/Outputs/Reviews
  • Traceability Matrices
  • Project/Program Management
  • Product Development/Design
  • Design Drawings/Design Specifications
  • Design Verification/Validation
  • Material/Component/Supplier Specifications
  • Operating Procedures/Work Instructions
  • Set-Up/Start-Up Procedures
  • Process Development/Process Controls
  • Process Validations (IQ/OQ/PQ)
  • Process Capability
  • Voice of Customer/Market Research
  • Customer Requirements
  • Equipment Specification/FAT
  • Change Management
  • Inspection Procedures/Test Methods
  • Sampling Techniques/Sampling Plans
  • Critical Parameters/Critical Quality Attributes
  • Data Analysis/Statistical Analysis
  • ISO 9000/ISO 13485/ISO 14971
  • 21 CFR Part 11/21 CFR Part 820
  • Clinical Monitoring
  • Packaging Validation
  • Tolerance Analysis

SELECTED ACCOMPLISHMENTS

  • Lead role in the remediation of legacy combination product design history files
    • Remediation of over 30 combination products including oral solutions, transdermal patches, eye drops and IV products with various delivery devices (e.g. dosing spoons and cups, dropper bottles, medicine droppers)
    • Development and authorship of over 30 design history files and traceability matrices
    • Authored and facilitated design, process, and user FMEAs for numerous products
    • Development and authorship of risk management and risk benefit analysis for over 30 products
    • Developed and performed training for risk management process in accordance with ISO 14971
    • Lead design reviews for all products ensuring compliance with regulatory and internal standards
  • Completed design and development work for combination product manufacturer (drug-device), including:
    • Served as independent reviewer for all ISO 13485/ 21 CFR 820 design reviews on combo syringe-drug device
    • Lead project team for design and development of a hydrophilic urological coated catheter
    • Lead project team for remediation of quality issues related to IV drug pumps and tubing kits
    • Co-authored and facilitated user, design, and process FMEAs
  • Managed/assembled Design History Files for manufacturer of multiple devices, including
    • Managed/assembled DHF for coated urological catheter from concept thru design verification
    • Managed/assembled DHF for new Intrauterine Pressure Catheter from concept thru commercialization
    • Managed/assembled DHF for new Dual Helix Fetal Scalp Electrode from concept thru commercialization
    • Managed/assembled DHF for new Safety Pen needle from concept thru design verification
    • Managed/assembled DHF for mechanical sphygmomanometers
  • Performed multiple DHF gap analyses for medical device manufacturer of medical lasers and laser ablation catheters, including:
    • Performed in-depth gap analysis of Quality System for compliance to 21 CFR part 11 and ISO 13485
    • Performed DHF gap analysis for multiple laser ablation catheters
    • Performed DHF gap analysis for medical lasers for compliance to IEC 60601-1, IEC 60601-2, and IEC 60825-1
    • Assembled Software Traceability Matrix and identified gaps for adherence to IEC 62304
    • Performed design transfer gap analysis to internal design controls from transferring manufacturing of medical laser from UK to US
    • Audited risk management documents for compliance to ISO 14971
  • Assembled multiple retroactive Design History Files for manufacturer related to legacy devices, including
    • Updated/created DHF for Intrauterine Pressure Catheter
    • Updated/created DHF for Neonatal Catheter Insertion Device
    • Updated/created DHF for Single Helix Fetal Scalp Electrode
    • Assisted in updating/creating DHF for pen
  • Authored and conducted training for Design Control SOP for manufacturer, including:
    • Authored numerous internal design control SOPs in accordance with ISO 13485, ISO14971, and 21 CFR 820 for IVD devices
    • Conducted training for numerous Design Control SOPs for IVD devices including phased development system, risk management and analyses, and process validation
    • Conducted training in planning, facilitation, and execution of risk analyses including PHA, FTA and FMEA
    • Conducted training in planning, facilitation, and execution of process validation for process validation including IQ, OQ, and PQ
  • Managed various project activities for medical device manufacturer of urological catheters, including:
    • Led product development project team overseeing activities in R&D, Quality, Marketing, Regulatory, Operations, and Finance, including budgeting and scheduling responsibility, and successful 510(k) clearance (K112137)
    • Resolved and diffused team dynamic and personality conflicts that existed between several team members
    • Wrote equipment specifications for various automated equipment (60ppm), including dipping and punching equipment
    • Developed protocol and performed Factory Acceptance Testing (FAT) for automated equipment
    • Completed successful design transfer of automated manufacturing equipment from USA to international manufacturing locations
    • Developed test methods and characterized tensile behavior of catheters made from different materials
    • Resolved quality issue of leaking two-part molded valve resulting in mold changes
    • Trained junior engineers in design controls, statistical techniques, technical/design reviews, risk management, verification and validation activities, and FMEA
    • Developed innovative design for intermittent urological catheter leading to multiple patent applications
  • Managed various project activities for medical device manufacturer of safety pen needles and syringes, including:
    • Led product development project team overseeing activities in R&D, Quality, Marketing, Regulatory, Operations, and Finance including budgeting and scheduling responsibility
    • Wrote equipment specifications for various automated equipment (300ppm), including printing and packaging equipment
    • Performed Factory Acceptance Testing (FAT) for automated packaging equipment
    • Completed product development and design for safety pen needles resulting in multiple patent submissions
    • Lead team in development of process FMEA for automated equipment
    • Developed pilot molding strategy for building/implementing six 8-cavity steel molds from off-shore vendors to support design verification and clinical trials
    • Supervised mechanical engineers and design engineers in development of medical devices
    • Assessed, designed, and presented to management multiple device business opportunities with external pharmaceutical partners
    • Led training for design controls, statistical techniques, including sample size determination, and verification/validation activities to R&D staff of over 15 members
    • Led planning and implementation of VOC activities, including interviews and focus groups
    • Facilitated Intellectual Property Review Board committee for strategy/decisions for filing patents and/or holding IP as trade secrets
  • Managed various project activities for medical device manufacturer of obstetric catheters and devices, including:
    • Led product development project teams for multiple products resulting in three product launches
    • Developed/maintained risk analyses, dFMEA, design inputs, traceability matrix, and verification \validation activities
    • Performed process validation for elastomeric over-molding process
    • Managed external 3rd party suppliers and vendors in the design, development, and validation of cabling systems to connect developed disposable devices with existing fetal monitors in hospitals
    • Designed software algorithm to allow one-circuit board to meet needs of three different cabling systems
    • Performed supplier audits for electro-mechanical components
    • Designed and developed innovative test methods to simulate clinical use of devices in fluid environments
  • Managed various project activities for medical device manufacturer of stethoscopes and blood pressure monitors, including:
    • Led global product development with team members in three locations to support 510(k) clearance (K012455) and launch of shockproof mechanical blood pressure gage
    • Developed and validated semi-automated process to attach shockproof molded bumper to mechanical blood pressure gage
    • Resolved quality issues on manual production line including selecting proper adhesive and process flow improvements
    • Designed, developed, and tested thermoformed packaging tray for cardboard shelf box to meet ISTA standards
    • Resolved quality issues and streamline design of molded disposable stethoscope resulting in $200k savings per year
    • Developed and validated testing methodology for incoming inspection of electronic stethoscopes
    • Performed supplier audits on molded and extruded components
  • Managed various project activities for medical device manufacturer of ex-vivo blood separation devices, including:
    • Designed multiple sterile high volume disposable injection molded components for blood flow separation, including flow restrictors and rectangular channel connectors
    • Resolved quality issues with multi-lumen PVC tubing eliminating delamination
    • Designed and validated peristaltic pump blood delivery systems and software algorithms for blood flow separation procedures resolving accuracy issues
    • Coordinated and performed clinical monitoring at international Sites (Western Europe), including development of clinical protocols and clinical database management
    • Acted as key member of technical staff and liaison to field service to help resolve technical issues in real time

PROFESSIONAL EXPERIENCE

  • QSN – Remediation Consultant – 10/14 – present
  • Canon Life Sciences – Quality Engineer Consultant (Rockville, MD) – 03/13 to 10/14
  • Hospira, Program Manager -Contract Consultant (Lake Forest, IL) – 08/12 to 02/13
  • Quality Solutions Now, Inc., Consultant (Emmaus, PA) – 07/12 to present
  • Angiodynamics, Quality Engineer-Contract Consultant (Marlborough, MA) – 04/12 to 08/12
  • Bard Medical, Senior Program Manager (Covington, GA) – 06/10 to 02/12
  • Becton Dickinson, Staff Engineer (Franklin Lakes, NJ) – 09/06 to 05/10
  • Tyco Healthcare/Kendall, Principal Engineer (Ludlow, MA) – 03/03 to 09/06
  • Welch Allyn, Sr. Project Engineer (Arden, NC) – 04/98 to 02/03
  • COBE Laboratories, Project Engineer/Clinical Monitor (Lakewood, CO) – 02/90 to 12/97 Self Employed,
  • Engineering/Quality Assurance Consultant (Denver, CO) – 04/89 to 10/91
  • COBE Laboratories, Biomedical Engineer (Lakewood, CO) – 02/87 to 05/89
  • International Volunteer, Global Organizations (Greece, Germany, UK) – 06/86 to 01/87
  • Shiley, R&D Project Engineer (Irvine, CA) – 06/84 to 05/86

EDUCATION

  • Master of Engineering in Mechanical Engineering, University of California Berkeley – 5/84
  • Bachelors of Science in Engineering Mechanics, University of Illinois Champaign/Urbana – 5/81

TRAINING

  • Certified Biomedical Auditor, ASQ – 12/16
  • Certified Quality Auditor, ASQ – 6/15
  • Certified Quality Engineer, ASQ – 2/14
  • Design Control Training, Canon Life Sciences – 2/14
  • Regulatory Environment and Submissions, Bard Medical – 2/11
  • Advanced Leadership Training, Becton Dickinson – 7/09
  • Six Sigma Green Belt Training, Becton Dickinson – 6/08
  • Quality Sampling Plans, Becton Dickinson – 3/08
  • CAPA Training, Becton Dickinson – 8/07
  • Design of Experiments, Tyco Healthcare – 2/05
  • Phase Gate Product Development, Tyco Healthcare – 8/04
  • Leadership Training, Center for Advanced Leadership – 4/02
  • Advanced Bonding Techniques, Henkel – 7/01
  • Statistical Process Control, COBE Laboratories – 3/90
  • Behavior of Plastics/Rheology, American Society of Plastics – 5/88

AFFILIATIONS

  • 8,109,883 – Cable monitoring apparatus – Granted 2/12 
8,801,673 – Safety Pen Needle Assembly Having Shield for Non-Patient End – Granted 8/14
  • WO2009102596 – Safety Needle Assembly
  • WO2009114762 – Safety Pen Needle Assembly w/ Shielding for Patient & Non-Patient Ends
  • US20110118667 – Hub Assembly Having A Hidden Needle For A Drug Delivery Pen
  • US20080177168 – ECG Lead Wire Organizer and Dispenser
  • US20080082024 – Signal replication medical apparatus
  • US20060073728 – Intrauterine Pressure Catheter Interface Cabling System