Tracy Lopes Email & Phone Number

New Brunswick, Nj, Us

• Leading the end-to-end Robotics & Digital Surgery supply chain (plan/source/make/deliver) to support the Monarch Robotics Platform• Drove the expansion of capabilities of the organization in 24 months recruiting and developing key diverse leaders in an extremely competitive environment.• Doubled production volumes of consumables every year and expanded capital equipment manufacturing to meet growing customer requirements enabling the business to grow the installed base.• Completed the selection, funding, construction and validation of a new 70k+ sq. ft. facility to manufacture consumables for the robotics’ business.• Developed and implemented a 10-yr supply chain strategy to meet production volumes, improve profitability, identify key suppliers and partners and develop strong talent to prepare the business to exceed $1B in revenue in 5-7 years.• Drove key partnerships with R&D, quality and commercial to balance short-term business needs with long term strategic plan commitments

Palo Alto, Ca, Us

Palo Alto, Ca, Us

Franklin Lakes, New Jersey, Us

General management responsibility for > $400M worldwide P&L including clinical instrumentation, reagents, software and services.- Exceeded Clinical 2017 revenue target by ~$19M, market leader in Clinical Flow Cytometry- Rebuilt Clinical marketing and innovation teams with direct management of the Marketing Team and Program Managers- Launched multiple clinical instruments and reagents- Delivered unique external partnership to expand instrument capability- Executed a complete Clinical Strategy Refresh to identify next market opportunities- Responsible for ~$400M revenue Clinical business and Product Development budget

Raritan, Nj, Us

Global leader of in vitro diagnostics serving the Clinical Laboratory and Immunohematology communities.- Accountable for development of the total product portfolio for the Ortho Clinical Diagnostics business ($1.2B)- Own the business strategy review, led trade-offs across business units, ensure key milestone approval to accelerate delivery of key programs by 6 months- Led the following core functions: Portfolio Management, Program Management, Business Insights and Product Development Governance- Accountable for the program management and budget expertise within Ortho Clinical Diagnostics- Accountable to optimize and define the product development process to drive efficiency through Ortho Clinical Diagnostics- Accountable to develop business KPIs for Ortho Clinical Diagnostics

Raritan, Nj, Us

- Lead the Clinical laboratory Line of Business team - lead in the definition, management and execution of key strategies to support $1.2MM business- Provide commercial value through the application of sound project management strategies for delivery of new products to the market. Currently managing 8-10 programs and annual program budget of $26MM- Lead the Governance Process for the total Ortho Clinical Diagnostics Business, including Portfolio Management, Product Development and Lifecycle Maintenance- Responsible for managing the R&D budget ($41MM) – both development and oversight- Lead team of Program Managers (6) responsible for a portfolio of in vitro diagnostic development programs.

Raritan, Nj, Us

• Global R&D leader with experience in building the product development teams to commercialize product. • Lead the development of the strategy for the China team to ensure a robust pipeline and capabilities• First expat to China to establish the emerging market Product Development team, hire, manage, and retain the team members. • Lead the execution of the 1st China-Designed J&J medical devices development successfully through FDA 510Kand SFDA approval. • Lead the buildup of two sites within China to design and development market appropriate product

Raritan, Nj, Us

• Promoted through the Leadership Development Program at EES• Led a cross functional team to develop a Harmonic device for upper GI/Colorectal

Raritan, Nj, Us

• Led First Plastic Surgery Voice Of the Customer activities for R&D team• Coordinated Surgeon Key Customer Visits for the Plastic Surgery team• Led a cross functional team to implement an IP software system • Coordinated transfer of production line from Cincinnati to Juarez Mexico• Developed IP Landscape for the Orthopedic and Plastic Surgery areas• Filed five patent applications in the Orthopedic and Plastic Surgery areas

• Established/Managed the Pilot department, 1 supervisor & 22 operators over 2 shifts.• Established/Managed the Process Dev. Eng. department including 3 engineers and 7 technicians.• Manager of the manufacturing engineering team, 6 engineers & 1 technician.• Coordinate the Pilot team activities, including implementation for 5 NPD projects.• Managed the implementation of Lean manufacturing in the production area to increase overall productivity & yields. The process was implemented in 6 wks with a savings of 750K.• Managed the feasibility, development and implementation of a new etching process into production estimated savings $400K.• Aided in the creation and implementation a new simplified method of change control to clarify the system and reduce engineering time.• Supervised the documentation and interview preparation room during Pre FDA audit; subsequently led an audit response team• Assisting in NDC’s strategic planning process

Miami Lakes, Fl, Us

• Lead project team of 2 engineers and 3 technicians through design verification/validation, process validation and launch of stent product in 6 months ahead of business plan• Led stent process development & commercialization between 3 company sites (one international)• Drafted (AutoCAD) stent designs and corresponding machine code to laser cut stents• Supervised several designed experiments (DOE) to optimize manufacturing • Conducted early finite element analysis on varying stent designs• Developed manufacturing processes, documentation and fixtures for AAA device• Conducted process FMEA of three stent designs for AAA product• Prototyping of conceptual stents utilizing both new stent designs and materials.• Worked with CAD and CAM packages to develop laser programming for prototype designs. • Maintain laser laboratory and pilot plant scheduling to provide an efficient turn around • Developed and implemented the Laser Safety Program.