Lead product compliance business process projects.

Lead complex enterprise level programs. Role required collaboration with business partners and managing cross-functional teams to define business processes, scope, budgets, risks, resource plans, timelines, technology and/or policy implementation.

Responsible for managing business transformation, supply chain, compliance, new product development and variable cost productivity projects. Budgets range in size from $100K to over $5M. Project teams are larger than 40 people comprised of Global and Regional Marketing, Sales, Regulatory, Registration, Quality, Research and Development, Supply Chain, Legal, Customer Service, Finance and Executives. Typically manage 3-5 projects simultaneously. Experienced with concept to post-market launch product development cycle requirements including FDA 510(k) submissions.

Responsibilities included managing department consisting of two Mechanical Engineers, one Principal Electrical Engineer and one Technician, developed department budget and forecasted expenses and resource hours quarterly. Worked with site team to address product complaints and manufacturing issues.

Responsible for new product development and sustaining engineering of medium and high volume Infusion Disposable, Pressure Monitoring and Interventional Imaging products from concept to commercialization. Developed several medium and high volume infusion disposable products with cumulative sales since launch over $10M (photo-opaque administration set, needle free sample site, stopcock, administration sets, Hemodraw™). Collaborated with Marketing to identify customer requirements, Regulatory to develop 510(k) submissions and Technical Files, Operations to setup and validate molding and production lines and external vendors including tool design approval, tool qualification and contract negotiation.

Responsible for project management and mechanical design on mobile phone accessories from concept to commercialization. Worked with Product Management to identify product requirements. Development responsibilities included concept brainstorming, detailed design, ECAD analysis, tolerance and FEA analysis, print generation, supplier management, tool approval, design qualification as well as project management responsibilities. Lead Mechanical Engineering team of 5 in the US and mentored a design team in Shanghai, China. Commercialized 12 products with combined revenue greater than $220M. Inventor on 9 US patents.