Heather M. Schulze Email & Phone Number

Wilmington, Delaware, Us

Boston, Massachusetts, Us

Marlborough, Ma, Us

• 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

Kalamazoo, Mi, Us

• 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

Kalamazoo, Mi, Us

• 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

Kalamazoo, Mi, Us

• 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

Kalamazoo, Mi, Us

• 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

Kalamazoo, Mi, Us

Denver, Colorado, Us

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

Houston, Texas, Us

• 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.