S2insight delivers project management training courses, planning Intensive™ sessions, and custom engagements to medical device, pharmaceutical, and life sciences organizations in the United States and internationally.

Medical Device Tier 1 supplier developing/manufacturing minimally invasive therapy delivery systems (guidewires, catheters) • Manage program of interrelated projects for next-generation mitral valve replacement delivery technology, including scope, timeline, risk, and cost management as well as dependencies and priorities between projects• Lead structural heart therapy delivery catheter projects through DFM, development, and process/equipment IQ/OQ/PQ• Guide cross-functional teams through risk management/mitigation strategies and root cause analysis tools/techniques

• Develop and control project schedule, product cost, and adherence to quality systems in highly regulated medical industry • Support site consolidation in relocating and offshoring manufacturing resources producing $50 million revenue annually• Spearhead site development and implementation of MS project templates across portfolio of new development projects

Develop and manufacture vehicular controls to meet demanding specifications in industrial applications• Managed project portfolio spanning new product introductions, sustaining (supply chain / regulatory), and cost improvement initiatives at all stages of the development cycle and across manufacturing sites in the USA, China, and India• Supervised 2 direct report project managers and 1 direct report drafting / document support specialist• Led new opportunity evaluation, review, and approval with management team, including preparing financial analysis and liaising between global sales and local technical teams

Consumer Products company developing and marketing premium skincare products under direction of Dr. Nicholas Perricone• As the first to bring formal project management discipline to a small company, implemented program management tools and processes which enabled communication and performance of a lean development team and led to improved metrics• Led a global matrix team of 20+ people in delivering $25 million product portfolio of new products to 8 key customers• Implemented and facilitated project governance, stage-gate development, forecasting, and reporting tools• Hired and managed a direct report project manager, and coach cross-functional team members

• Led engineering (mechanical, electrical, systems) project teams in design, development, and manufacture of Karma, GoPro’s first aerial drone, including projects for interfacing battery and charging products/accessories.• Focused on early iteration prototyping and testing to rapidly advance timing required by designing from the ground up• Managed direct report and external resources (consultants, contract manufacturers) including contract/SOW negotiation

• Implemented in-market product changes for camera and accessory products, including flagship Hero4 camera line• Established early field failure program using Agile methodology and JIRA software: facilitated root cause analysis, prioritized and resourced change backlog, and managed implementation of product changes• Identified and executed product cost and supply chain improvements with annual impact in millions of dollars

Consumer Electronics company developing and marketing cases with designs engineered and tested for device protection• Led innovation project team in conception, design, and engineering of novel materials and electronics into phone cases• Directed full concept-to-launch lifecycle of Candyshell Faceplate product line, which became a best-selling product• On-site oversight of product manufacturing in China, and effective communication across cultures and time zones

• Led R&D teams in developing and commercializing 8 new consumer products (sunscreens, cleansers)• Collaborated across marketing, operations, sales, quality, and regulatory functions • Designed clinical studies in tandem with external clinical sites and authored in-depth scientific documents for claims support and FDA submissions

• Held roles in Product Development, Clinical Affairs, and Technical Assurance / Quality Engineering • Authored clinical protocols, product specifications, manufacturing instructions, and SOPs• Stressed innovation and capitalized on opportunities beyond scope of pipeline projects

• Researched method for accurately localizing electrodes (ECoG) by analyzing brain scan data (pre-op MRI and post-op CT)• Assisted faculty and graduate researchers in development of brain-machine interface devices and algorithms

• Developed hardware and software for testing electronic components of continuous-flow blood apheresis machines• Ensured accurate documentation of technical details of testing platform, devices under test, and software algorithms