Business Development & New Ventures Intern @ Medtronic Vascular
Universidade de São Paulo
MBA/ Ph.D/ Medical Device: An enthusiastic solution-focused team leader with extensive experience in managing medical devices product development from initial requirements through post launch. Proven ability to bridge technology and business goals with a unique blend of business acumen and technical knowledge. Very effective working in highly technical and scientific environments. Capable of building strong relationships across
MBA/ Ph.D/ Medical Device: An enthusiastic solution-focused team leader with extensive experience in managing medical devices product development from initial requirements through post launch. Proven ability to bridge technology and business goals with a unique blend of business acumen and technical knowledge. Very effective working in highly technical and scientific environments. Capable of building strong relationships across organizations. Proficient in French and Portuguese.
Areas of expertise: Medical Device Design Control, Phase-Gated Product Development. Design For Manufacturing Practices; All applicable regulation for medical devices
Genomics Program Manager @ From December 2013 to Present (1 year 11 months) San Francisco Bay AreaSenior Program Manager @ • Oversight of product profile, business plans, program plans, specifications and requirements, financials and resource allocation to support new product development or on-market modification
• Development of complex products encompassing embedded and application software, mechanical and electrical components, disposables and accessories from initial requirements through post-market surveillance. Products include blood glucose meters for consumer and hospital markets, strips, sensors data management software and accessories such as cables, cradles
• Handled localization, SKU allocation, initial forecasting, and BOMs. Managed projects in all phases of development from concept phase through post launch. Delivered all projects on time and within allocated budgets
• Supported regulatory strategy for regulatory submissions in the US and abroad (FDA, ANVISA, Health Canada, CE). Highly proficient in applicable regulation: ISO 15197/13485, FDA 21 CFR Part 820, CE marking process
• Planned, developed and supported human factors, marketing claims and other clinical studies for products in several different categories.
• Highly proficient in human factors engineering and usability requirements for medical devices, sterilization methodologies
• Led the development of new packaging for meters and strips balancing requirements and costs (200+SKUs) developing an efficient roll-out strategy to support the business needs
• Managed $8MM budget for the R&D organization, monthly managing variations to within 5% of estimates
• Developed literature (training material, user manuals, exterior labeling, web material), for several products – disposables, software, devices for sales support, training materials
• Frequently delivered presentations to senior management – President, DVPs, Directors – to report in program and technical development
• Experienced in CAPA and Quality and Regulatory audits.
• Scrum Master certified From August 2007 to November 2013 (6 years 4 months) Alameda CaliforniaBusiness Development & New Ventures Intern @ • Analyzed and presented several license transactions to Senior Management (President, General Counsel, Area General Managers). Developed the financial analysis and implemented due diligence processes including coordination of Medtronic functional and business unit personnel
• Performed strategic and market analysis for proposed transactions, including assessment of strategic objectives and relationship/fit with those objectives
• Company liaison with third parties, lawyers, business unit and corporate functional resources From May 2006 to August 2006 (4 months) Staff Scientist @ • Led the development of new optical diagnostic devices for non-invasive blood glucose monitoring. Developed comprehensive technology evaluation, technical specifications, cost structure and schedule for product prototype
• Developed in-vivo protocols for trials to test bench prototype
• New product design technical expert in optics and algorithm development
Detector Engineer (2001-2002)
• Developed technology evaluation benchmarks and specifications From November 2001 to May 2005 (3 years 7 months) Education Program Manager @ • Developed strategies and relationships for introduction and penetration of Celoxica products in the US. Created a new market for the product and initial revenue of approximately $100K/quarter From April 2001 to November 2001 (8 months) Postdoctoral Researcher @ • Capable and well-trained lecturer and speaker. Developed and taught courses at Berkeley’s Physics department for classes of 35-40 students - a research based freshman astronomy class. Consistently received excellent teaching and communications ratings.
• Deep understanding of Federal and other grants award processes. Wrote and obtained grants to develop and deliver education and outreach materials in astronomy and physics for middle and high schools. Organized and led several summer teacher workshops in the US and abroad to increase science literacy - Astronomy and Physics From October 1998 to April 2001 (2 years 7 months) Fundamental research @ • Proposed, developed and executed novel experiments in nuclear physics to probe the nature of matter working alongside Nobel Laureates
• Published over 20 articles in professional refereed journals and delivered several presentations at International conferences
• Served as project manager for several physics experiments managing engineers, vendors, students and projects annual budget From January 1994 to April 2001 (7 years 4 months)
MBA, Strategy, Corporate Social Responsibility and Technology Management @ University of California at Berkeley - Walter Haas School of Business From 2005 to 2007 MS, Nuclear Physics @ Universidade de São PauloPh.D, Nuclear and Particle Physics @ Universite Bordeaux III Maria Isaac is skilled in: Market Analysis, Due Diligence, Management, Executive Management, Finance, Marketing, Process Engineering, Programming, Physics, Valuation, Functional Leadership, Materials Management, Product Development, Business Planning, Cross-functional Team..., Product Management, Medical Devices, Project Management, Strategic Planning, Competitive Analysis, Design Control, Pharmaceutical Industry, Certified Scrum Master..., R&D, Commercialization, FDA, CAPA, Product Launch, Program Management, Clinical Trials, Strategy, Business Development, Start-ups, Biotechnology
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