Alex T. Bourdon


Consultant


Highly accomplished medical device executive helps clients compete successfully using effective, efficient, compliant systems. Combines manufacturing expertise with solid quality and compliance experience to develop and implement systems and culture that enhance cross-functional collaboration. Skilled in product quality improvement, lean manufacturing, continuous improvement, service, strategic planning and budgeting, change management, plant turnarounds, due diligence, consolidations, new product launches. Background in in-vitro diagnostics (chemistry, immunochemistry, microbiology, and hemostasis instruments, reagents and consumables) at the platform level and point-of-care, plus powered surgical cutting and stapling products.

CORE COMPETENCIES

  • Change Management
  • Operations Management
  • Project Management
  • Production and Process Development/Controls
  • Design Controls/Change Controls
  • Production and Materials Planning
  • Lean Manufacturing/Continuous Improvement
  • Purchasing Controls
  • Identification and Traceability
  • Acceptance Activities
  • Nonconforming Product
  • Corrective and Preventative Action
  • Complaint Investigations
  • FDA Inspections/Remediation
  • ISO Audits/Gap Analysis/Internal Audits
  • Risk Management/FMEA/Hazard Analysis
  • Buildings and Facilities
  • Equipment
  • Labeling and Packaging Control
  • Handling, Storage, Distribution and Installation
  • Supplier Management
  • Preventative Maintenance
  • Organization and Personnel Sales and Operations Planning

SELECTED ACCOMPLISHMENTS

  • Cleared existing regulatory warning letters at multiple companies ranging in size from $10 million to $100 million to $1.7 billion, including:
    • Upgraded quality management systems to meet regulatory requirements, plus customer requirements, and align with efficient manufacturing requirements.
    • Retrained workforces and assured rigorous and disciplined compliance with new quality management systems requirements by managerial, technical and operational staff.
    • Wrote periodic progress reports to FDA.
    • Managed FDA and Notified Body inspections.
    • Redesigned and re-registered products as necessary.
    • Converted adversarial relationship between robotic surgical equipment company and FDA to collaborative relationship, avoiding warning letter and enabling initial public offering exceeding $200 million.
    • Converted adversarial relationship between a $100 million point of care legacy division of a public company and FDA to collaborative as part of FDA inspection and warning letter clearance.
  • Created and implemented manufacturing strategy for large global manufacturer of central laboratory diagnostic instruments and consumables, including:
    • Developed manufacturing strategy aligned with corporate strategy (acquiring executive and board approval) and implemented across multiple domestic and international plants and multiple product lines, reducing costs and inventories, increasing customer service levels and improving product quality.
    • Demonstrated routine year-over-year standard cost reductions of 5% on a $300 million/year budget.
    • Developed buy-in of Sales & Service, Marketing, Finance, Quality Assurance and Regulatory and other functions so that implementation was cross-functionally aligned and smooth.
  • Consolidated multiple plants, simultaneously improving product quality, customer supply, and process efficiency, without generating regulatory observations, including:
    • Consolidated full operating plants of acquisition targets to existing plants.
    • Consolidated critical OEM supplier operations and products to most appropriate plants, consistent with manufacturing strategy.
    • Transferred operations across company locations to leverage most effective quality management systems and minimize organizational/logistical/technical/time boundaries.
    • Included consolidations from international to domestic and vice-versa.
  • Implemented self-sustaining continuous improvement programs at multiple sites ranging from 100 employees to 1500 employees in $850 million chemistry/immunochemistry business, including:
    • Utilized Lean, 6Sigma, and Theory of Constraints as key elements within volunteer-driven Kaizen offices to continuously identify, improve, and track results of opportunities within the various sites and across all Functions to eliminate waste of all kinds.
    • Reduced instrument service turnaround time for point-of-care company by 85%.
    • Reduced floor space (at constant product volume) at one site from 300k sq. ft. to 50k sq. ft.
    • Achieved 6 sigma and higher quality performance at multiple sites.
    • Designed and implemented multiple automation projects to reduce labor, improve safety, and improve product quality.
  • Developed and implemented manufacturing launch strategy for major new central laboratory diagnostic platform.
    • Integrated multiple testing technologies and high degree of automation.
    • Developed quality plans early in product development stage to assure congruence with manufacturing strategy and quality and regulatory requirements.
    • Reduced original model for inventory by more than $200 million.
    • Developed synchronized production flow system.
    • Developed and validated in-process test modules aligned with production system.

PROFESSIONAL EXPERIENCE

  • Medical Manufacturer Consulting, LLC, President (Wilmington, DE) – 5/12 to Present
  • International Technidyne Corporation, VP Manufacturing & Operations (Edison, NJ) – 5/09 to 4/12
  • Delcard Associates, COO (New Castle, DE) – 5/08 to 4/09
  • Power Medical Interventions, Inc., COO (Langhorne, PA) – 11/06 to 4/08
  • Dade Behring, VP Global Reagent & Consumable Mfg (Glasgow, DE) – 9/02 to 11/06
  • Dade Behring, VP Global Instrument Mfg (Brookfield, CT) – 9/99 to 9/02
  • Dade Behring, Director of Mfg (Glasgow, DE) – 1/96 to 9/99
  • DuPont Medical Products, Mfg Manager (Glasgow, DE & Newtown, CT) – 4/92 to 12/96
  • DuPont Engineering, Various titles (Wilmington, DE; Aiken, SC; Richmond, VA) – 2/81 to 4/92

EDUCATION

  • Bachelor of Science, Mechanical Engineering, University of Delaware, Newark, DE – 9/76 to 12/80

TRAINING

  • Complaint Handling, ITC – 3/12
  • Universal Precautions, ITC – 1/12
  • Performance Management, ITC – 1/12
  • Validation, ITC – 11/11
  • Design Controls, ITC – 10/11
  • FMEA/Hazard Analysis, ITC – 6/11
  • Corrective And Preventative Action, ITC – 5/11
  • Good Documentation Practices, ITC – 2/11
  • Nonconforming Product, ITC – 5/10
  • Preventive Maintenance, ITC – 4/10
  • DMAIC, ITC – 3/10
  • Training Process, ITC – 2/10
  • Product Design & Development , ITC – 1/10
  • Quality Policy, ITC – 11/09
  • Managing For Innovation, Customer Manufacturing Group – 6/09
  • Hiring for Performance, Vistage – 8/08
  • Project Management System, Delcard Associates – 8/08
  • How To Mind Read Your Customers, Lucas Consulting – 4/08
  • Becoming A Strategic Leader, Center For Creative Leadership – 5/06
  • Leading Change, Yale University – 1/06
  • Negotiations, Wharton School of Business – 11/05
  • Six Sigma Leadership, Forereach Consulting – 9/04
  • Mergers & Acquisitions, Wharton School of Business – 6/04
  • Financial Management, University of Chicago – 11/03
  • The Perfect Engine, TBM Consulting Group – 2/03
  • Managing Media Communications, Dade Behring – 7/02
  • Lean 101, Dade Behring – 1/00
  • QSR for Medical Devices, DuPont – 6/98
  • Financial Management Of A Business, DuPont – 3/95
  • Operational Excellence, Partners For Excellence – 8/94
  • ISO Quality System Requirements, DuPont – 2/94
  • Materials Requirements Planning II, Ollie Wight – 2/93
  • Supplier Quality Auditing, DuPont – 7/92
  • Medical Products Development Framework (PACE), DuPont – 5/92
  • Effective Speaking and Human Relations, Dale Carnegie Group – 3/91
  • See You At The Top, Zig Ziglar – 11/89
  • Process Management, DuPont – 1/85

AFFILIATIONS

  • University of Delaware, Department of Mechanical Engineering:
  • Alumni Relations Committee – 06/11 to Present
  • Program Development Committee – 06/05 to Present
  • Delaware Diamonds Society – 06/05 to Present
  • University of Delaware, College of Health Science Advisory Board – 03/03 to Present
  • University of Delaware, Alumni Wall of Fame – 6/08
  • Mechanical Engineering Distinguished Career Award – 6/05
  • Zig Ziglar, Instructor: Strategies for Success – 5/90
  • Vistage – 3/05 to 11/06 and 6/08 to 5/09
  • Juvenile Diabetes Research Foundation (Fundraising Recruiting Chairman in 2005) – 1/03 to 12/05
  • New Castle County Business Executives Forum – 1/03 to 12/06
  • American Association for Clinical Chemistry – 1/96 to 12/06

AWARDS

  • University of Delaware, Alumni Wall of Fame – 2008
  • University of Delaware, Mechanical Engineering Distinguished Career Award – 2005
  • University of Delaware, Alumni Walk of Fame – 2011
  • New Jersey Governor’s Safety Award – 2011
  • Delaware Governor’s Quality Leadership Award – 2005
  • Dade Behring Project Management Excellence – 1998
  • DuPont Engineering Excellence (twice) – 1991 and 1992
  • Dale Carnegie (twice) – 1989 and 1990