Brett Casey Email & Phone Number

San Diego, California, United States

Lead Research and Development Program Management Organization with focus on new product development and product improvement. This 20 person team drives portfolio management and core team leadership for all new product development and major product improvements. Under my leadership the team has developed and launched G6 Pro, G7, Stelo, Dexcom ONE, Dexcom ONE+ and many product improvements while establishing portfolio management and product development processes.

San Diego, California

Lead organization of new product development core team leaders, program managers and systems engineers. Partner with VP Strategic Marketing in managing the New Product Portfolio.

Greater San Diego Area

Director, Program Management Provide Hologic core team and cross-company leadership for development of new fully automated molecular in vitro diagnostic (IVD) products with anticipated annual revenue greater than $40M. - Core Team Leader for new product development teams across both TMA and PCR technology platforms working with both internal and external development teams. Scope includes leadership for financial, business phase gates, design control, schedule and decision making throughout the project, while leading focused sub-teams as project demands. Design and development includes US market scope with FDA presubmission, clinical trials and US FDA 510(k) submission. - Established C-level business relationships with development partner and manage the steering committee.

Carlsbad, Ca

Emerge Diagnostics developed, manufactures and markets the Electro-diagnostic Functional Assessment (EFA) which identifies and locates soft tissue injuries. Provide Executive Leadership and execution for a Type II medical device startup. Key Achievements:  Lead operations with full responsibility for bottom-line factors, including FDA compliant manufacturing, quality system and regulatory compliance, supply chain, account implementation and management and tech support.  Established manufacturing system including NetSuite ERP System, bill of materials, supply chain, manufacturing procedures and quality controls. Sourced alternative components and vendors to save 15% on the initial BOM.  Established field operations organization, processes for product implementation, technical and customer support.  In first 8 months established an FDA compliant Quality Management System for Type II medical device including over 120 controlled documents and 2 Design History Files; gained ISO13485 and CMDCAS certification.  Collaborated with CEO on site selection and lease terms then led all aspects of facility build-out and readiness.

Greater San Diego Area

Alere manufactures and markets rapid diagnostic tests with annual revenue of $2.4 billion. Managed 2 sites with P&L responsibility for a Drugs of Abuse point of care product manufacturer with over 250 employees and annual revenue of $40M. Key Achievements:  Directed sites with full responsibility for FDA regulated manufacturing, research and development, quality assurance, regulatory compliance and supply chain.  Redefined the organizational structure and hired a leadership team with both Product Line and Functional Roles.  Implemented lean manufacturing and six sigma methods and streamlined cumbersome processes in manufacturing and quality assurance.  Increased annual output from 6 million to 13 million units while increasing annual revenue from $9M to $40M.  Improved on-time delivery from 65% to 97%, cost per unit by 10% and manufacturing efficiency by 30%  Successful ISO13485 and FDA audits and dramatic reduction in CAPA, Complaint and Change Request durations.  Successfully cleared 2 FDA Special 510k's and developed a forensic use only product in one month under full CFR Design Control – more than $1M in revenue for this product in the first year.

Greater San Diego Area

Director of R&D (2010-2011) R&D Program Manager (2009) Directed a product development organization of 10 employees and pilot manufacturing plant of 20 employees while also the program manager for key assay product development and commercialization efforts generating products with expected annual revenue of $12 Million in US and EU. Key Achievements:  Responsible for leading an R&D development team as well as cross-functional programs from concept through commercialization for FDA submission and CE Mark. Program teams included R&D, clinical affairs, quality assurance, regulatory affairs, marketing and manufacturing resources.  Beta HCG immunoassay development effort achieved company record time from feasibility to clinical enrollment and widest dynamic range of any product in company history.  NT-Pro BNP product was developed and successfully marketed and achieved CE Mark and European distribution.  Instituted cross-company portfolio management and executive dashboard metrics for key programs.  Streamlined the design control process, removing 25% of the deliverables while improving compliance.

Greater San Diego Area

Director of Engineering (2007-2009) Sr. Manufacturing Engineer (2006-2007) Directed an organization of 24 engineers across three major product lines in Cardiology, Hemostasis and Cholesterol generating annual revenue of over $380 Million. Key Achievements:  Led a transformation of the group to be customer-driven and results oriented. The scope of the position included all aspects of organizational planning, budgeting and staffing.  Restructured the group multiple times to deal with rapidly shifting business conditions including acquisitions and 2 major facility consolidations.  Engineering responsibilities: equipment, process and product development, and IQ/OQ/PQ validations.  Improved product precision from 11% to 8% CV, improved assembly line run rates by 20%, reduced scrap by 25% by implementing new process equipment and improving existing processes.  Led cross-functional teams through structured problem solving to resolve mission critical lines-down production issues. Utilized tools such as Fault Tree Analysis and FMEA to get to root cause and implement solutions.  Selected for 2009 prestigious Inspirational Leadership Program and 2007 Biosite “Be Courageous” Award.

Chandler, Az

Engineering Manager (2002-2006) Sr. Equipment Development Engineer (1997-2002) Managed an engineering organization of 6 engineers working with US and Asian suppliers developing manufacturing automation equipment for microprocessor assembly and testing. Key Achievements:  Collaborated with suppliers to develop and implement high speed pick and place and thermal control equipment.  Deployed an install base of over 1500 tools ($600 million) across factory locations in the America’s and Asia.  Implemented Lean Manufacturing practices - improving operational efficiency by 40% across 5 factory locations.

Ms, Mechanical Engineering

Bs, Nuclear Engineering