Werner Hafelfinger
Biomedical Industry – Consultant & Advisor at Biomedical Independent Consultant | Ventura County, California, United States
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Werner Hafelfinger is a seasoned Biomedical Industry Consultant and Advisor, renowned for his extensive expertise in guiding organizations through the complexities of product development and regulatory compliance. Currently operating as an independent consultant, he plays a pivotal role in leading product initiatives from conception through clinical processes to market release. With a robust background in biomedical engineering, Werner excels in establishing strategic direction and operational frameworks that not only meet compliance requirements but also drive innovation within the medical device sector.
His current projects often involve advising startups and established companies on critical aspects such as regulatory submissions, international clinical trials, and the formation of strategic alliances. Werner's deep understanding of design controls and risk management allows him to provide invaluable insights into operational structure diligence and financial management, ensuring that organizations can navigate the intricate landscape of the biomedical industry effectively. His ability to weigh risk versus benefit is particularly beneficial for companies seeking funding or looking to optimize their product development processes.
As a recognized speaker and subject matter expert, Werner frequently shares his knowledge on best practices in commercialization and program management, empowering teams to enhance their product development strategies. His leadership skills and experience in manufacturing engineering further bolster his capacity to guide organizations through the challenges of bringing innovative medical devices to market. With a commitment to fostering collaboration and driving results, Werner Hafelfinger continues to be a vital resource for companies aiming to thrive in the competitive biomedical landscape.
Biomedical Industry – Consultant & Advisor at Biomedical Independent Consultant in January 2014 to Present
Vice President Operations at V-Wave Medical Ltd in January 2016 to Present
VP Operations, Technology Incubator at St. Jude Medical in December 2005 to January 2014
Vice President, Operations at Savacor Inc in January 2002 to January 2005
President at Quallion in January 2002 to January 2004
VP Operations / Chief Operating Officer (COO) / Director at Pacific Aerospace & Electronics in January 1999 to January 2002
Vice President, Global Manufacturing, Cardiac Rhythm Management Divisions at St. Jude Medical in January 1989 to January 1999
Vice President, Research & Development at Siemens Pacesetter in January 1984 to January 1989
Vice President, Research & Development at Spectrolab in January 1982 to January 1984
Senior Director of Operations at Micro Electronics Marin - Switzerland in January 1977 to January 1982
Project Manager at General Instrument in January 1973 to January 1977
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Medical Device Consulting
Medical Devices
ISO 13485
FDA
Cross-functional Team Leadership
Design Control
Quality System
Biomedical Engineering
Design of Experiments
R&D
CAPA
Validation
Program Management
Commercialization
Product Development
DMAIC
Six Sigma
Capital Equipment
Manufacturing
V&V
Continuous Improvement
Quality Assurance
GMP
Product Launch
Design for Manufacturing
Quality Management
Process Engineering
Manufacturing Operations
Start-ups
Leadership
Management
Manufacturing Engineering
Start-up Consulting
Clinical Trials
U.S. Food and Drug Administration (FDA)
Research and Development (R&D)
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What is Werner Hafelfinger email address?
Email Werner Hafelfinger at [email protected]. This email is the most updated Werner Hafelfinger email found in 2026.
How to contact Werner Hafelfinger?
To contact Werner Hafelfinger send an email to [email protected]. (updated on October 31, 2024)
What company does Werner Hafelfinger work for?
Werner Hafelfinger works for Biomedical Independent Consultant
What is Werner Hafelfinger's role at Biomedical Independent Consultant?
Werner Hafelfinger is Biomedical Industry – Consultant & Advisor
What is Werner Hafelfinger's Phone Number?
Werner Hafelfinger's phone (213) ***-*111
What industry does Werner Hafelfinger work in?
Werner Hafelfinger works in the Hospitals And Health Care industry.
Werner Hafelfinger Email Addresses
Werner Hafelfinger Phone Numbers
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