~ Seasoned Medical Device Product Management Executive eager to contribute significant global experience and outstanding project leadership talents toward supporting a dynamic company in optimizing bottom-line performance. ~
20 years of experience in regulated medical device industry with proficiency in strategic planning, market analysis, business process standardization, cost control, and continuous improvement. Solid reputation for exemplary vision, organizational skills, technical acumen, decision-making abilities, and success in streamlining global operations. Critically assess business operations to determine and optimize fiscal performance, sustainability, competitive positioning, and revenue opportunities; excel in marketing and brand management. Merge polished leadership and team-building talents to hire, train, motivate, mentor and manage highly-productive and cross-functional personnel in multiple locations worldwide.
- Tenaciously directed improvement efforts for Phonak in Europe and Asia to enhance manufacturing efficiency by up to 50%, reduce labor costs, and expedite product delivery by an average of 40%.
- Assembled and led GN ReSound teams in designing and implementing customized flow manufacturing production systems to advance product delivery time by 50%, decrease remake rates, and double annual inventory turns.
- Innovatively established a Global Recovery Operations Center from the ground up to process returned instruments from internal manufacturing sites, providing a recurring annual savings of over $2M for GN ReSound.
- Orchestrated implementation of flow-based lean manufacturing systems for GN ReSound in US, Japan, and Spain to elevate production throughput up to 50%.
- Slashed product subassembly variations by 80% for Siemens Hearing, significantly reducing worldwide inventory and manufacturing costs.
- Positioned Siemens Hearing as #1 global industry leader through strong expertise in coordinating process and product quality improvements worldwide.
Phonak Hearing Systems AG, Stäfa, Switzerland, 2004 to Present
Director, Product Manager C Custom Products
- Proficiently direct product development and launches, product and systems validation, technical support, and ongoing staff development.
- Define Key Performance Indicators to measure and improve processes at 25 global subsidiaries; improved custom product growth volumes by 20% annually.
- Directed Canadian software development team in global electroacoustic test system product management.
- Positioned company to outperform industry competition while improving product development, release validation and quality processes, and accelerated speed to market.
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Professional Experience continued
GN ReSound Corporation, Redwood City, CA, 1997 to 2003
Senior Director, Global Technical Operations, Tåstrup, Denmark (2003)
Director of Global Technical Operations
- Built globally-dispersed team of 25+ to provide synchronized technical services, service training and new product introduction.
- Strategically transferred product manufacturing to facility in China, increasing efficiency and quality while effectively decreasing operating expenditures.
- Developed and delivered programs to standardize production and service activities at 19 locations and boost overall efficiency and product quality.
- Directed full-scope product development for embedded systems PCMCIA card hearing aid programming system.
- Achieved continuous product improvement by managing team of 3 sustaining engineers to diligently monitor product performance, conduct root cause quality analysis, and identify optimum solutions.
- Steered regulatory compliance inclusive of FDA correspondence, 510(k) submissions, and adherence to ISO 0000 xxxxxx xxxx , xxxx , xxxxx 00000, JIS, Health Canada, and international requirements.
- Exhibited outstanding versatility in authoring product service manuals and technical communications documents, overseeing divisional staffing, and administering budget of $2M+.
Siemens Hearing Instruments, Piscataway, NJ, 1993 to 1997
International Faceplate Division Manager
- Relocated several distributed manufacturing locations in Europe and the U.S. to Singapore and Indonesia, effectively improving product quality and reducing manufacturing costs and overhead.
- Expedited new order delivery time from approximately one week to one day for 90% of product orders through seamless implementation of Demand-Flow manufacturing systems into major worldwide subsidiaries in Europe, Asia and the U.S.
- Initiated, designed, and launched corporate website to achieve online presence.
- Resourcefully established international manufacturing training center in Minneapolis, Minnesota to fortify global product technical education while minimizing expenses and travel costs.
Prior background includes role as Product Manager, Picture Archiving & Communication Systems, Siemens Medical Systems, Iselin, NJ, 1985 to 1993.
B.S. Degree, Electrical and Biomedical Engineering, Rutgers University
Professional Development & Training:
Business Plan Development, Sales and Presentations
Marketing Concepts and Business Planning
Certified in Demand-Flow Manufacturing
FDA, ISO 9000 and International Standards
Private Pilot, Instrument rated
Hiring Agent Name
I am currently seeking a challenging career opportunity in a senior-level product development or management capacity and am submitting my resume for your review. In advance, thank you for your time and consideration.
I bring to you a considerable background in the regulated medical device industry, with demonstrated proficiencies in strategic market analysis, project management, spearheading global operations, and identifying and implementing cost-saving, quality, and process improvement opportunities. To complement these qualifications, I offer sharp critical thinking, planning, organizational, forecasting, and team leadership expertise.
As a proactive contributor to your organization, you will find me to be a highly motivated and technically savvy leader committed to supporting you in achieving your objectives through superior self-initiative and stellar prioritization skills. I am confident that I could be a valuable asset to <insert name of organization>, and look forward to hearing from you soon.
Yyyyyy x. yyyyyy
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