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BILL JACQMEINMedical Device ExecutiveBusiness Strategy • Product Development • Clinical Research • Regulatory/Quality • Operations/ManagementOrganizational Leader with significant hands on experience driving product innovation and business process strategy including several first-in-world products and complex global business transformations.Has a proven track record of turning around struggling opportunities and leading organizational success.Successful experiences leading complex programs and multi-functional organizations in both large and small companies.Regarded as a people centric leader – building and leading world class teams and delivering products, programs and results on time and on budget.Deep functional expertise in various medical device products and the following disease states: Oncology, Radiology, Cardiology, and Neurology.www.primepathmedtech.com
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Chief Executive OfficerPrime Path Medtech Oct 2019 - PresentGreater Minneapolis-St. Paul Area -
Managing Director - Medical Device/BiotechnologyRcq Solutions Jul 2013 - Oct 2019Greater Minneapolis-St. Paul AreaProvides Consulting for small to mid size medical device companies across several functional areas (Business Strategy, Regulatory, Quality, Clinical, and Operations)
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Vp Business DevelopmentOriel Stat A Matrix Oct 2016 - Sep 2018Greater Minneapolis-St. Paul Area -
CooVergent Bioscience Jul 2014 - Sep 2016Greater Minneapolis-St. Paul AreaResponsible for Operations, Marketing, Sales, Regulatory, Quality, Customer Service and R&D Key Responsibilities:• Created a company from acquired IP• Established and manage Operations/Manufacturing/Marketing/Sales/R&D• Initiated a Quality System (ISO 9001 in process)• Develop and manage R&D product portfolio• Design and implement a Sales and Marketing strategy• Provide review and recommendations for new business opportunities
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Chief Technology Officer - R&D/Clinical/Regulatory/OperationsGalil Medical Sep 2009 - Jan 2014Arden Hills, MnResponsible for clinical, regulatory, medical affairs, quality, US operations, technical service and R&D worldwide Key Responsibilities:• Corporate Officer • Develop and implement clinical/regulatory strategy• Develop and manage product portfolio• Responsible for overall annual budget (> $10M)• Provide review and recommendations for new business opportunities• Manage 8 direct reports with oversight of 25+ indirect reports
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Vice President, Ww Clinical And RegulatoryGalil Medical Jan 2008 - Sep 2009Arden Hills, MnResponsible for all clinical programs, regulatory submissions and overall quality support for the company worldwide
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Director, ClinicalBoston Scientific Mar 2004 - Dec 2007Greater Boston AreaResponsible for all clinical aspects of all oncology product lines (>500 products; $250M worldwide revenue) from design through commercialization Key Responsibilities:• Member of Oncology division and Endovations operating board • Developed and implemented clinical/regulatory strategy for all product lines (Phase I - IV)• Responsible for department annual budget (> $8M)• Provided review and recommendations for new business opportunities• Led Clinical Key Opinion Leader and government agencies relationships (NCI, CMS, FDA)• Managed 11 direct reports with oversight of 40+ indirect reports -
Director, ClinicalProxima Therapeutics 2001 - 2004Alpharetta, GaResponsible for all clinical aspects of all product lines from design through market launch Key Responsibilities:• Developed and implemented clinical strategy for all product lines• Responsible for clinical department budget • Negotiate and prepare study contracts with clinical sites and national study organizations• Developed project management tools to manage clinical projects• Provided clinical input to new product development and business opportunities• Prepared and reviewed scientific publications • Evaluated new/synergistic technologies (Breast biopsy, Spinal applications)
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Manager Clinical AffairsProxima Therapeutics 1998 - 2001Alpharetta, GaKey Responsibilities:• Provided clinical specifications for the design phase of product development• Assisted in testing and qualification of product including preclinical animal studies • Designed, implemented, and managed multiple clinical IDE protocols• Analyzed, compiled and reported clinical data for FDA and other regulatory agencies • Provided product demonstrations and training for customers and field personal• Provided 24 hour technical support and handle questions from all customers • Supervised full time staff Clinical Research Associate• Supervised contract site monitors, data handling and biostatistical personnel for all Studies• Developed budget and contracts for all clinical studies and investigational sites
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Clinical Program ManagerSulzer Intermedics 1995 - 1998Houston, Texas AreaResponsible for managing all clinical aspects of tachycardia products from design through market launch • Provided clinical and marketing specifications for the design phase of product development of advanced dual chambered defibrillators and defibrillation leads• Assisted in testing and qualification of product including animal studies if needed• Designed, implemented, and managed multiple clinical IDE protocols for PMAs• Analyzed, compiled and reported clinical data for FDA and other regulatory agencies • Provided product demonstrations and training for customers and field personal• Provided 24 hour technical support and handle questions from all customers (physicians, nurses, field personnel, and patients) concerning commercial and clinical products• Created database specifications for storage and retrieval of information
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Clinical Research AssociateCyberonics 1993 - 1995Clear Lake City, Texas• Assisted in design and implementation of clinical studies (PMA/IDE)• Provided field technical support for the physicians during implant • Compiled, verified, and analyzed clinical study data• Prepared reports for various submissions to the FDA• Fielded questions from study physicians, nurses, and patients• Designed databases for storage, tracking, and retrieval
Bill Jacqmein Skills
Bill Jacqmein Education Details
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Bioengineering
Frequently Asked Questions about Bill Jacqmein
What company does Bill Jacqmein work for?
Bill Jacqmein works for Prime Path Medtech
What is Bill Jacqmein's role at the current company?
Bill Jacqmein's current role is CEO at Prime Path Medtech, Inc..
What is Bill Jacqmein's email address?
Bill Jacqmein's email address is bj****@****ail.com
What is Bill Jacqmein's direct phone number?
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What schools did Bill Jacqmein attend?
Bill Jacqmein attended Texas A&m University.
What skills is Bill Jacqmein known for?
Bill Jacqmein has skills like Medical Devices, Business Strategy, Fda, Clinical Research, Biomedical Engineering, Surgery, Iso 13485, Product Launch, Medical Imaging, Quality System, Market Development, Cardiology.
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