Vice President Operations
Current
V-Wave Medical Ltd
Jan 2016 - Present
AeroLeads people directory · profile
Werner Hafelfinger Email & Phone Number
Biomedical Industry – Consultant & Advisor
at
V-Wave Medical Ltd
1 work email found
@sjm.com
LinkedIn matched
✓ Verified August 2026
4 data sources
Profile completeness 100%
Current company
V-Wave Medical Ltd
Role
Biomedical Industry – Consultant & Advisor
Location
Ventura County, California, United States
Who is Werner Hafelfinger? Overview
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Quick answer
Werner Hafelfinger is listed as Biomedical Industry – Consultant & Advisor at V-Wave Medical Ltd, based in Ventura County, California, United States. AeroLeads shows a work email signal at sjm.com and a matched LinkedIn profile for Werner Hafelfinger.
Werner Hafelfinger previously worked as Vice President Operations at V-Wave Medical Ltd and Biomedical Industry – Consultant & Advisor at Biomedical Independent Consultant. Werner Hafelfinger holds Master Of Science (Ms), Mechanical Engineering from Columbia University.
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{first_initial}{last}@sjm.com
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Profile bio
About Werner Hafelfinger
BIOMEDICAL INDUSTRY – CONSULTANT & ADVISORLeading product initiatives … from concept through clinical process & market releaseLeads and manages teams, projects, and corporations in establishing, developing, and restructuring products and operations and startups. Significant experience establishing processes, strategic direction, and controls that meet compliance and regulatory submission requirements in both the U.S. and European Union. Fluent in German and French.Strong innovative competencies in finding technical and design solutions to challenges; 12 US and international patents – issued. Facilitates and establishes relationships and works with Physician Key Opinion Leaders (KOLs).EXPERTISE & ADVISORY:> Identifying Solutions to Medical Clients’ Problems > Analyzing Product Needs; Engineering & Technical Guidance> New Project Start Up Leadership – including setting Company Structure, Joint Ventures, Licensing > Establishing Quality / Regulatory Requirements & Systems - for Class I to Class III Medical Device CompaniesLEADERSHIP COMPETENCIES:Product Development | Project Management | International Regulatory Compliance GLP | Product Design | Design Controls | Process & Product Validation and Verification | Marketing StrategiesRegulatory Submission Processes Product Control Procedures | Documentation RequirementsNegotiating Business Agreements | Operations
Listed skills include Medical Devices, R&D, Fda, Product Development, and 32 others.
Current workplace
Werner Hafelfinger's current company
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V-Wave Medical Ltd
11 roles · 54 years
Werner Hafelfinger work experience
A career timeline built from the work history available for this profile.
Biomedical Industry – Consultant & Advisor
Current
Biomedical Independent Consultant
Advising organizations on compliance, regulatory, and operational design. Provides guidance on: company, product and marketing strategies; regulatory submissions; international clinical trials; industry partnerships; negotiating strategic alliances; operational structure diligence; identifying funding; financial management - weighing risk/benefit; and finding design solutions. Speaker and Subject Matter Expert on design controls, product and process validations.
2014 - Present
~12 yrs 7 mos
Vp Operations, Technology Incubator
Led, coordinated, and managed all aspects of operations integration, including Manufacturing, Engineering, Clinical, Quality, Regulatory Strategies, and Product Development.Core Products: LAP (Left Atrial Pressure) Monitor Module & Lead and CRT devices, Implant Tools & Procedures, LaCrosse Transeptal Puncture, and HeartPOD Delivery System.> Guided and proctored physicians and clinicians - during medical device implants.
Dec 2005 - 2014
Vice President, Operations
Led all Operations including finance, planning, product development, clinical, and regulatory. Established best practices. Developed LAP device and implant tools and procedures.Core Products: Medical implantable device to manage CHF (Congestive Heart Failure) with Hemodynamic monitoring.> Guided and proctored physicians and clinicians - during medical device implants.> Led transition team integrating Savacor operations into St. Jude, post-acquistion.
2002 - 2005
~3 yrs
President
Led company including operations and restructuring.Core Products: Developing / producing advanced Li-ion designs rechargeable technology and primary batteries for implantable medical device, aerospace, and defense industries.
2002 - 2004
~2 yrs
Vp Operations / Chief Operating Officer (Coo) / Director
Pacific Aerospace & Electronics
Led strategic planning initiatives through collaboration with customers (e.g. Boeing, Airbus, GE) and Medical Device companies. Developed innovative and advanced technology and cross-divisional implementation for new and emerging market segments.>Led successful global restructuring; consolidated operations; implemented ISO & GMP compliance; achieved certification and financial control.
1999 - 2002
~3 yrs
Vice President, Global Manufacturing, Cardiac Rhythm Management Divisions
Led global manufacturing operations, design, implementation, engineering, and manufacturing of Cardiac Rhythm systems.Core Products: Cardiac rhythm management product systems.> Developed and managed Hybrid and defib Capacitor component manufacturing operation.> Drove significant improvements in reliability and quality compliance for medical products.> Team leader in company acquisitions and integration, including operational due diligence.
1989 - 1999
~10 yrs
Vice President, Research & Development
Siemens Pacesetter
Led R&D Operations for product development.Core Products: Advanced cardiac pulse generators, leads and programming systems; Insulin Infusion systems.> Setup and managed the VLSI design facility in designing CMOS custom and semi-custom ICs.
1984 - 1989
~5 yrs
Vice President, Research & Development
1982 - 1984
~2 yrs
Senior Director Of Operations
Micro Electronics Marin - Switzerland
1977 - 1982
~5 yrs
Project Manager
General Instrument
1973 - 1977
~4 yrs
1 education record
Werner Hafelfinger education
-
Columbia University
FAQ
Frequently asked questions about Werner Hafelfinger
Quick answers generated from the profile data available on this page.
What company does Werner Hafelfinger work for?
Werner Hafelfinger works for V-Wave Medical Ltd.
What is Werner Hafelfinger's role at V-Wave Medical Ltd?
Werner Hafelfinger is listed as Biomedical Industry – Consultant & Advisor at V-Wave Medical Ltd.
What is Werner Hafelfinger's email address?
AeroLeads has found 1 work email signal at @sjm.com for Werner Hafelfinger at V-Wave Medical Ltd.
Where is Werner Hafelfinger based?
Werner Hafelfinger is based in Ventura County, California, United States while working with V-Wave Medical Ltd.
What companies has Werner Hafelfinger worked for?
Werner Hafelfinger has worked for V-Wave Medical Ltd, Biomedical Independent Consultant, St. Jude Medical, Savacor Inc, and Quallion.
How can I contact Werner Hafelfinger?
You can use AeroLeads to view verified contact signals for Werner Hafelfinger at V-Wave Medical Ltd, including work email, phone, and LinkedIn data when available.
What schools did Werner Hafelfinger attend?
Werner Hafelfinger holds Master Of Science (Ms), Mechanical Engineering from Columbia University.
What skills is Werner Hafelfinger known for?
Werner Hafelfinger is listed with skills including Medical Devices, R&D, Fda, Product Development, Iso 13485, Cross Functional Team Leadership, Biomedical Engineering, and Design Control.
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