Heather M. Schulze

• Responsible for leading Hologic’s entry into pelvic health through organic and inorganic pipeline development • Obtained multi-million-dollar funding for an innovative class III surgical device projected to increase annual revenue $80M+ in 10 years • Directed strategic pivot of IDE clinical trial protocol design to enable PMA application and early commercial success • Established division's product investment process that accelerated the quality and quantity of pipeline opportunities assessed and increased roadmap visibility • Guided creation of new core brand strategy, messaging, and content for the hysteroscopy portfolio and supported it's launch at the National Sales Meeting • Identified and prioritized business development targets; analyzed product-market fit and modeled financial projections during three due diligences

• Portfolio and pipeline owner of $165M surgical booms, lights, and tables portfolios; oversaw market research programs, roadmap development, user needs definition, and profit & loss estimates • Revamped $90M surgical light product roadmap balancing small and large-scale innovation and integrating resource planning • Led turnaround of $30M loss-leader surgical table portfolio resulting in a profit generating business and enabling new investment in future growth • Managed voice of sales team responsible for bi-directional product innovation guidance and feedback • Big Picture Marketing Coach that empowered teams globally by leading multi-day training courses and providing mentorship on marketing plans

• Led global multi-disciplinary teams through new product development of class II medical devices in compliance with FDA Design Controls • Defined project timelines, budget and resource requirements, obtained management buy-in, and executed within agreed upon constraints • Reviewed and approved sustaining engineering activities in compliance with FDA Change Control as a member of the Enterprise Change Request Board • Managed project discovery activities to determine technical and financial feasibility and viability

• Developed and managed macro- and micro- level design verification and validation plans, coordinated internal and external resources, and executed within budget and equipment constraints • Led the identification of customer needs and development of design specifications for new products • Wrote and executed detailed design verification and validation test protocols ranging from simply type tests to complex reliability tests • Collaborated with international development partners to optimize design, resolve test failures, and meet customer requirements • Developed expertise in applying Human Factors to product development and designed and executed formative and summative usability studies

• Created designs and supported test, manufacturing, risk and quality documentation for new product development projects in compliance with FDA design controls • Planned, executed, and implemented customer specials, CAPAs and sustaining engineering projects • Led New Product Request process with key OEM supplier • Evaluated and contributed to New Product Development, New Product Request, and Enterprise Change Request process improvements • Developed automated SolidWorks CAD templates and associated processes to align CAD development across the business • Intern 2006; Full time 2007-2001

• Designed and organized research project combining material sciences with bioengineering applications • Learned and applied cell culture laboratory technique

• Very Large Scale Integrated Circuit (VLSI) artwork composition for the level two data cache and signal interconnect routing for the bus interface unit of an enterprise computing class 64-bit microprocessor. Responsibilities included ensuring that all signal routes met design rules and timing delay objectives.