Medical Device Supply Chain

Summary

Cover Letter

CurrentLocation US: Castro Valley, CA

Industry

Other / Micellaneous

Compensation

Current: 150000

Desired: 150000

WillingtoRelocate Yes

PreferredLocations,

Travel Availability

MyPerfect Job

DesiredTitle

Cover Letter

Dear hiring manager, I am a seasoned professional in the medical device industry with 20 years expertise in product management, new product introduction and operations management. I have held Director and Sr. Director level responsibilities with global companies leading cross-functional product management, development, technical support and operations teams. I have hands-on experience with both large scale and small high volume medical devices, product life cycles, P/L, new product introduction, supply chain and business systems structure. I also bring to the table extensive international business and cultural knowledge including 5 years living in Switzerland and Denmark. My experience is extensive with strategic project planning and management, technical operations, hardware and software development, systems validation and technical support within industry leading companies.

Highly organized, I maintain a strategic vision while effectively translating that vision to both technical and non technical levels within project teams and across departments. I have a proven track record for structuring and leading coordinated global project teams. My communication and presentation skills have been honed to an effective professional level from years of developing and delivering technical product education seminars around the world.I am experienced building relationships and leading diverse multinational professionals to achieve corporate goals on time and within budget. I have a solid reputation for creating value through innovation, integrity and effective global team building. I look forward to speaking further about how I can apply my experience and skills to benefit your organization and becoming part of your team. Sincerely, Gary Roesel

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Resume

MEDICAL TECHNOLOGY OPERATIONS EXECUTIVE

SUMMARY

Results-driven professional with 20 years experience leading international medical device product and project teams, coordinating new product introductions, managing product life cycles and streamlining global operations. Strong skills in analyzing complex systems and devising solutions to meet strategic business and performance objectives. Adept at guiding diverse teams to deliver top performance. Culturally sensitive and successful leader with extensive international work experience in the medical device industry.

PROFESSIONAL SKILLS

Product Management, Medical Device Industry

Business Process analysis and improvement

Operations Process Standardization

Coordination of complex international projects

Global team building in matrixed organizations

Sustaining engineering project management

New Product Introduction

Demand-flow lean manufacturing implementation

Integration following corporate mergers or acquisitions

Leadership and creative problem solving

Communication and technical education

EXPERIENCE

Phonak Hearing Systems AG

Director, Custom Products & Services

Stfa, Switzerland 2004 - Present

Global product management, custom hearing instrument development, new product introduction, product and systems validation and technical support and education. Established international product competence center at Phonaks headquarters in Switzerland to increase custom product market share in the US market and internationally.

Restructured custom product business, implemented strategic planning, mechanical and electrical product development, process validation processes and streamlined global manufacturing. Established effective working teams, processes and system alignment. Simplified product structure, reduced local inventory costs and increased supply chain efficiency.

Implemented global Key Performance Indicators to measure and improve processes. Directed process alignment and operational improvement projects in Europe and Asia resulting in 20 50% manufacturing efficiency, reduced labor costs, and up to 40% improvement in product delivery times. Custom product growth volumes improved 20% within the first year and continued similar growth in following years.

Responsible for global electroacoustic test system product management, overseeing Canadian design team. Established software and hardware release contents and development priorities, and coordinated system deployment, installation, training and upgrades.

Company advanced to a leadership position in custom products, outpacing industry competitors while improving product development, release validation and quality processes, and improved speed to market. Averaged two product family launches annually, under two brand names

GN ReSound Corporation

Senior Director, Global Technical Operations

Tstrup, Denmark / 2003

Developed and implemented business restructuring plan for global operations, focused on product design for service, technical documentation and global technical services to international subsidiaries and distributors. Close interfaces with Supply Chain Management, Product Development, Sales & Marketing and Manufacturing to lower costs, improve performance and increase profitability.

Established execution-oriented teams based in Copenhagen headquarters to design and implement customized Flow Manufacturing production systems in German, Scandinavian and other international facilities. Improved product delivery time by 50%, decreased remake rates and doubled annual inventory turns.

Structured and established a Global Recovery Operations Center in the Free Trade Zone in Xiamen, China. The center processed returned instruments from global internal manufacturing sites; performed component analysis and testing, and released certified spare parts into the supply chain. Implemented from concept to full operation within one year, providing an annual savings of over $2M USD.

GN ReSound Corporation

Director

of Global Technical Operations

Redwood City, CA / 1997 - 2003

Established and managed an effective international team providing synchronized technical services, technical training and new product introduction globally. Team consisted of over 25 people based in five locations in three countries encompassing operations, sustaining engineering, manufacturing, logistics, service, sales support and technical training responsibilities.

Developed and implemented corporate manufacturing standards and performance metrics. Worldwide product quality and consistency improved, while rework and repair rates decreased. Supported the team responsible for implementation of flow-based lean manufacturing systems in US, Japan, and Spain, which improved production throughput up to 50%.

Global supply chain and logistics team member involved with strategic product transfer from manufacturing locations in the U.S.A., Austria, Ireland, Netherlands and Denmark to manufacturing facility in China. Analyzed local product variations and production methods, and streamlined production of subassemblies. Increased manufacturing efficiency and quality while decreasing operating costs.

Directly supported custom manufacturing and repair operations at corporate subsidiaries in 19 countries. Supported operations at licensed distributors in over 20 additional countries. Developed, scheduled and implemented programs to standardize and improve manufacturing and service procedures, production efficiency and product quality.

Directed complete product development cycle for an embedded systems PCMCIA card hearing aid programming system. Coordinated hardware, firmware and software design, component specification, custom tooling, packaging, certification, custom test systems development and contract manufacturing. Product speed, size and cost were significantly improved versus competing products.

Directed global business process improvement teams to achieve maximum financial benefit from product and process standardization efforts including improved efficiency, increased inventory turns, lower inventory costs and faster service response times.

Designed and implemented global system for continuous product improvement and sustaining engineering activities. This system was integrated as a front end to the corporate global ECO process. Managed team of 3 sustaining engineers to monitor product field performance, perform root-cause analysis of quality issues, propose and qualify solutions, document and release product changes.

Implemented programs to improve communications, technical information and quality of services provided to worldwide affiliates. Designed, developed, coded and maintained proprietary technical web site which became benchmark for future company communications.

Wrote, released and distributed product Service and Repair manuals and technical communications. Responsible for Spare Parts pricing strategy, price book development and distribution to global subsidiaries and distributor chain.

Managed medical device regulatory affairs activities in the U.S. Responsible for FDA correspondence and 510(k) submissions. Supported ISO 9000, QSR, EN46001, JIS, Health Canada and other international homologation requirements. Experienced with product life cycle management.

Responsible for complete divisional administration including staffing, recruiting, personnel issues, expenditures and budget management of over $2 M.

Siemens Hearing Instruments

International Faceplate Division Manager

Piscataway, NJ / 1993 - 1997

Implemented a focused corporate approach to product planning, new product introduction and interdepartmental communication. Resulted in more effectively targeted products, faster speed to market, smoother transitions from R&D to manufacturing and increased product serviceability.

Reduced product subassembly variations by about 80%, significantly reducing worldwide inventory and manufacturing costs. Managed subassembly pricing and transfer costs worldwide.

Transferred several distributed manufacturing locations in Europe and the U.S.A. to central manufacturing and distribution locations in Singapore and Indonesia. Resulted in improved product quality and reduced manufacturing costs and overhead.

Championed implementation of Demand-Flow manufacturing systems into major worldwide subsidiaries in Europe, Asia and the U.S.A. Reduced new order delivery time from approximately one week to one day for 90% of product orders, while increasing product quality and reducing remake rates.

Planned, equipped and managed an international manufacturing training center in Minneapolis, MN. Operation of this facility improved the quality, content and consistency of global product technical education while reducing expenses and travel costs.

Initiated, designed, developed and maintained Corporate Web site (www.siemens-hearing.com). Recognized as one of the most comprehensive and informative web sites in the hearing industry at the time.

Responsible for U.S. FDA regulatory affairs activities including 510(k) submissions, product labeling, U.S. literature and marketing content approval.

Planned and conducted annual worldwide manufacturing meetings to implement standardized manufacturing improvements and increase product quality. During this time period, Siemens Hearing became the number one global industry leader.

Coordinated technical aspects of major industry trade shows, including equipment planning, pre-staging, setup, training and logistics.

Siemens Medical Systems

Product Manager, Picture Archiving & Communication Systems

Iselin, NJ / 1985 - 1993

Managed U.S. market activities for the PACS product line. Gathered customer requirements; wrote competitive analyses and product specifications; prioritized development activities with R&D; Performed product validation; developed application materials; Planned and implemented marketing and promotional programs.

Coordinated PACS market and business development within the United States and Germany. Planned and implemented all technical, regulatory, logistic and strategic aspects of new product introductions to the U.S. market.

Provided technical service and applications support to all U.S. sales locations and customers at clinical sites. Produced and provided on-site seminars focused on product sales techniques, technical features, competitive performance, and end-user applications.

Planned, scheduled and oversaw all aspects of product promotion at major U.S. trade shows. Included personnel assignments, staff training and demonstration strategy, logistics, product presentation and marketing message.

EDUCATION

B.S

. Electrical and Biomedical Engineering / Rutgers University, 1985 Tau Beta Pi Honor Society

Marketing Concepts and Business Planning

Demand-Flow manufacturing certification and implementation.

FDA, ISO 9000 and International standards

Internet Web Site Development

Business Plan Development, Sales and Presentation Skills

Conversational German & French language abilities

Windows 95/98/00/XP, Mac-OS, UNIX operating systems

Microsoft Office Suite

PageMaker, PhotoShop, Illustrator

Access database programming

Web design and maintenance including HTML, Javascript, ASP, Visual Basic and related technologies

Private Pilot, Instrument rated

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Contact Information

Gary Roesel

19571 Mt. Jasper Drive

Castro Valley, CA 94552

US

email *******@**************.***

Phone: 510-***-****

Industry: Other / Micellaneous

City: Castro Valley

State: CA

Zip: 94552

Country: US

Date: 20080918

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