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Summary

  • Senior operations executive with 25 years of progressive experience in medical device management, directing global manufacturing and supply chain operations from early stage to commercialization. Functions managed include engineering, supply chain, quality assurance, manufacturing, program management, facilities and EH&S.
  • Organizational leader who values relationships and develops employees; instilling a culture focused on customer satisfaction and continuous improvement; utilizing lean six sigma tools to achieve the highest standards of quality and productivity; maximizing growth and profitability. 
  • Extensive knowledge of efficient product development gained through experience developing and commercializing over 25 class III medical devices.  
  • Hands on, collaborative leadership style comes from over 12 years of entrepreneurial early stage, start-up experience with 6 companies; Novoste, World Medical, BKV, Heartware, Generic Medical and Cohero.    
  • Respect for maintaining the highest regulatory compliance comes from implementing quality systems and procedures at Fortune 500 companies Medtronic, J&J, and CR Bard.

Work History

2013Present

Vice President of Manufacturing and Supply Chain

COHERO HEALTH INC.

NEW YORK, NY, Report to President/CEO, a respiratory hardware and mobile application, Class II medical device start-up, with less than 10 employees, a remote position responsible for establishing supply chain strategy, sourcing contract manufacturing, supplier management, quality systems, customer service and distribution.

  • Sourced contract manufacturers in Asia and Europe.
  • Implemented the QMS compliant with FDA 21CFR 820 and ISO 13485.
  • Audited contract manufacturers to ISO 13485 and negotiated supply agreements. 
  • Coordinated design verification and validation testing to support FDA 510(k) submissions.
  • Established customer service and distribution with 3PL.
  • Scaled manufacturing capacity to supply US commercial launch.
20092013

Vice President of Operations

TERUMO HEART

ANN ARBOR, MI, Reported to President/CEO, full P&L responsibility for Class III, implantable LVAD Business Unit, which produces annual sales revenue of $50 million. Responsibilities include engineering, project management, manufacturing, supply chain and facilities comprised of 170 persons across 3 sites. Cascaded corporate strategy through the development of the business unit operations plan, managed direct spend budget of $15 million, established operations priorities and resource allocation across the business unit, and drove improvement projects to achieve key performance indicators.  

  • Developed and initiated Global S&OP meetings.  
  • Scaled operations to support commercial launch in Europe and Japan.
  • Transformed organizational culture through Lean Six Sigma implementation across the company.
  • Optimized project management and change control by championing the implementation of a PMO office.
  • Collaborated closely with R&D to develop Next Gen product ensuring design for manufacturing.
  • Insourced processes for precision machining, laser welding and lithium ion battery assembly.
  • Outsourced contract manufacturing of electrical products; controllers, charger, console and cables. 
20082009

Sr. Director Supply Chain

GENERIC MEDICAL DEVICES

PEMBROKE PINES, FL, Reported to COO, a virtual, start-up organization formed to challenge traditional medical device cost; responsible for managing CMO network, distribution, supplier quality and compliance.

  • Launched the first product in company history, a Class II urinary incontinence device.
  • Sourced contract manufacturers, negotiated supply and quality agreements. 
  • Established and maintained the validation master plan.
  • Implemented Made to Manage ERP system. 
20052008

Global Director of Operations

HEARTWARE, INC.

MIRAMAR, FL, Reported to COO, Head of Operations for this start-up, pre-revenue stage Class III medical device manufacturer of LVAD systems; responsibilities included manufacturing, engineering, supply chain and facilities; overseeing continuous improvement, day-to-day operations, and personnel development with growth from 3 to 75 persons. Promoted from Director of Manufacturing after 18 months.

  • Lead S&OP meetings to support commercial launch in Europe.
  • Implemented global consignment inventory system.
  • Implemented pump production yield monitoring system; improving yields from 45 to 80%.
  • Implemented QAD MFGPRO ERP system.
20032005

Co-Founder & President

BKV CORPORATON

PEMBROKE PINES, FL, co-founded and lead this company which provided consulting services to life sciences companies.

  • Established on-line commodity sourcing tool connecting engineers with suppliers.  
  • Lead manufacturing site transfer and process validation for Class III electronic medical devices.
  • Sourced components and contract manufacturing for a Class III structural heart product.
  • Sourced low cost API's in China for an emerging biotech company. 
19992003

Director of Manufacturing and Supply Chain

MEDTRONIC, FORMERLY WORLD MEDICAL MANUFACTURING CORPORATION  

SUNRISE, FL, Reported to VP, Operations; Head of Manufacturing and Supply Chain Operations for AAA Stent Graft Business Unit which manufactures a Class III medical device at multiple sites; annual sales growth from pre-revenue to $100 million; responsibilities included establishing annual operating objectives for 650 persons across manufacturing, engineering, supply chain and facilities; overseeing process excellence and continuous improvement programs; resource allocations to achieve operations goals; and ensure success of projects to achieve key performance indicators. 

  • Implemented lean manufacturing culture across the organization;
    • Reduced material cost from $1790 to $450 per device.
    • Reduced order to shipment time from 28 to 2 days.
    • Increased production yields from 60% to 96%.
  • Implemented QAD MFG-PRO ERP system.
  • Transferred manufacturing to Mexico and Santa Rosa, CA.
19981999

Sr. Materials Manager

NOVOSTE

NORCROSS, GA, Reported to COO, responsible for supervising 6 employees in purchasing, inventory control, and distribution.

  • Managed clinical supply chain during increase from 5 to 60 sites.
  • Member of QAD ERP implementation team.
  • Generated supply chain related procedures to support ISO 13485 certification.
  • Supported transfer of catheter process from MN to Scotland. 
19951998

Production Operations Manager

JOHNSON & JOHNSON, FORMERLY CORDIS ENDOVASCULAR

MIAMI LAKES, FL, Reported to General Manager; company manufactured Class III neuroradiology products, responsible for supervising and staffing growth in sales from $1 to $40 million, 5 to 125 employees, managed production, manufacturing engineering and supply chain. Promoted from Materials Supervisor in first year.

  • Increased production throughput by 25X on two manufacturing lines with lean manufacturing.
  • Reduced manufacturing cycle times from multiple weeks to 2 days by introducing single piece flow
  • Increased yields from 50% to 85%. 
  • Transferred manufacturing lines into a new facility.
  • Member of ISO lead team, generated Quality Manual and Procedures to achieve ISO 13485 certification.
  • Lead S&OP meetings coordinating the rapid commercial launch of 6 products in less than 18 months.
  • Negotiated raw material cost savings of $750,000 annually.
  • Implemented JDE ERP System.
19861995

Purchasing and Warehouse Manager

CR BARD, USCI DIVISION and BARD ELECTROPHYSIOLOGY

BILLERICA, MA, Reported to Supply Chain Director, responsible for supervising 15 employees in purchasing, inventory, and distribution.Held a succession of positions with increasing responsibility from. Sr. Distribution Planner, Materials Supervisor, Sr. Inventory Control Supervisor to Purchasing Manager.

  • Coordinated S&OP meetings across four manufacturing sites and six marketing channels.
  • Sourced contract manufacturer for the assembly of the Wizard inflation syringe.
  • Implemented lot size policies reducing work in process by $800,000.
  • Lead conversion of machined to injection molded components saving $200,000 annually.
  • Negotiated $120,000 annual savings in freight for sterilization logistics.
  • Implemented cycle counting program improving accuracy from 90% to 99%.
  • Collaborated with IT to design and implement PSS software to track work in process.
19831985

Sr. Production Control Planner

GCA

ANDOVER, MA, Reported to Production Control Manager, responsible for planning production of PCBA, wire harness and cables for this manufacturer of semiconductor capital equipment.

Education

19781983

Bachelor of Science

University of Lowell

Industrial Management

Certification and Training

19851986

CPIM

APICS
20102010

Lean Champion

World Class Manufacturing Association
20112012

Six Sigma Green Belt

Terumo Corporation
20082008

ISO 13485 Lead Auditor

RABASQ
20002000

Process Validation

Medtronic