Shelly Frank, Mba Email & Phone Number

United States

Irvine Ca

Irvine, California, United States

Lake Forest Ca

Lead a high volume of research and development projects related to eye care medical devices and ophthalmology products for both physicians and consumers, with budget oversight ranging from $100K to $15M per project. Accountable for scheduling, budget allocation, resource management, and collaboration with cross-functional teams to deliver product in alignment with defined scope of requirements. Oversee medical device process management for regulatory compliance, including Federal Drug Administration (FDA), 510K, and Q-Sub, quality assurance, clinical, manufacturing, and marketing for seamless processes and minimizing risk for product launches.

Mission Viejo Ca

Led full life cycle projects, with teams of up to 15 members, ensuring collaboration between technical, business, and artistic backgrounds to drive consensus. Implemented corporatewide process flow to generate more efficient allocation of resources and improve workflow and output across diverse business units. Throughout tenure, developed 25 products from inception and prototyping to high-volume manufacturing facilitate revenue growth. Developed and implemented resource and schedule planning, monitoring action-based deliverables, risk analysis, and market launch strategies to ensure seamless delivery of projects within scope, schedule, and budget. Implemented a new product management process in alignment with higher volume of product launches to maintain quality control, utilized as standard operating procedure. Designed procedures for marketing and product requirements (MRD/PRD) and scope statement process.

Foothill Ranch

•Directed 40, small and large, projects simultaneously at the Frontech North America division (FFNA).•Collaborated with the hardware & software engineering, marketing, Quality, and manufacturing departments.•Monitored engineering team workflow and enforced deadlines to ensure adherence to project timelines. •Drafted project plans, including comprehensive guidelines for project deliverables, and monitored work quality to guarantee sponsor and stakeholder satisfaction. Prepared and presented status reports to keep stakeholders and upper management up to date on project progress and developments.•Led multiple product development projects from conception to manufacturing to commercial release, including overseeing design, development, and validation of internal and third party products

Master Of Business Administration (M.B.A.), Business Administration And Management, General, 4.0

Master Of Business Administration (M.B.A.), Business Administration And Management, General