Bill Jacqmein Email & Phone Number

Greater Minneapolis-St. Paul Area

Greater Minneapolis-St. Paul Area

Provides Consulting for small to mid size medical device companies across several functional areas (Business Strategy, Regulatory, Quality, Clinical, and Operations)

Greater Minneapolis-St. Paul Area

Greater Minneapolis-St. Paul Area

Responsible 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

Arden Hills, Mn

Responsible 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

Arden Hills, Mn

Responsible for all clinical programs, regulatory submissions and overall quality support for the company worldwide

Greater Boston Area

Responsible 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

Alpharetta, Ga

Responsible 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)

Alpharetta, Ga

Key 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

Houston, Texas Area

Responsible 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

Clear 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