FRANCISCO FERNANDEZ

* ******* ****, ********, ** 01886 C: 781-***-**** acgq0e@r.postjobfree.com

Summary

Highly experienced, accomplished, and results driven R&D Development Leader. Unique ability to manage large international and multi-discipline teams, lead development and release innovative and complex medical equipment (Class I/II) in a highly regulated industry (FDA). Extensive experience managing large projects and groups of engineers (107+). Successful track record of enhancing team performance productivity, streamline processes and design robust products that exceed customer expectations and lead to significant increase in company revenues and profitability (70% revenue of $1 billion company).

Highlights

5-15 year strategic planning and budgeting Management of external design and consultant firms Talent identification and career development plans Leadership and team building Mentoring and coaching Development strategy and roadmap Technology leadership Process definition and improvement Project management Requirements and configuration management Scope management and control FDA, IEC, AAMI, IEEE, ISO Design controls Lean 6 sigma, DFSS Advance problem solving and root cause analysis

Agile CMMi SQA V&V OOA / OOD UML .Net, J2EE C++, C#, Java, XML, HTML, JavaScript Desktop app, embedded systems Client/Server, Web-based, mobile Windows, Linux, ThreadX, VxWorks, Nucleus SBC, Microcontrollers, FPGA Qseven, COM Express, ETX CANbus, USB, Ethernet, PCIe

Experience

R&D Director, Instrument Development

01/2014 to 11/2014 Instrumentation Laboratory

Bedford, MA Responsibilities - Led instrument development engineering activities targeting the Hemostasis and Blood Gas markets. - Responsible for the Electrical, Mechanical and Software Engineering departments (107+ FTEs). - Managed an annual budget of more than $18 million. - Led cross-functional computer architecture efforts towards development of the next generation of instrumentation.

Established cross-functional team and led trade-off and prototyping activities to drive selection of appropriated design and technologies based on user needs and system requirements (e.g. Qseven, COM Express, ETX, CANbus, USB, Ethernet, PCIe, FPGA, microcontrollers, OS, ARM, x86).

Accomplishments - Identified leads and structured the Electrical and Mechanical Engineering groups. - Designed mentoring, coaching and training programs to groom engineering group leads. - Initiated creation of standard operating procedures to streamline and harmonize practices within the Electrical and Mechanical Engineering groups (Using Lean methods). - Built Sustaining Engineering groups to isolate support from new product development activities. - Built Release Support group to harmonize and optimize engineering and product releases within R&D. - Designed and coordinated a DFSS (Design for Six Sigma) training and deploy program across R&D to improve overall product design and development (25 students, 5 projects).

Project selection targeted creation of new designs or improvements of existing solutions in areas such as packaging, fluidics, usability and sample handling. - Led development of 4 major on-going Hemostasis and Blood Gas instruments. Releases targeted for 2014 and 2015. - Led development of 3 data management solutions for POC Testing, Hemostasis Laboratory and Remote Service

respectively.

Other accomplishments while acting as R&D SW Director - Proactively designed and coordinated a 6 Sigma training and deploy program across R&D to improve existing processes, root cause analysis methods and overall quality of our instrumentation (50 certified students, 16 completed projects).

Projects primarily targeted yield, analytical performance improvements and reduction of complaints. - Managed system level projects involving consulting firms, suppliers, multidisciplinary engineering teams and internal stakeholders (Marketing, Quality, Manufacturing, Purchasing, Service). Used 6 Sigma to root cause source of variability and select optimal configuration using DOEs and statistical analysis.

Optics Module: Coordinated development and integration of a TRB (Time Results Fluorescence) optics module using MPPC technology (10% CV at 99th percentile). CO-oximeter: Led CO-oximeter project to replace obsolete component (CCD), increased yield (from 25% to 85%) and reduced measurement variability. CVP/pO2: Led complex system process/design improvement project involving electrochemistry sensors, control/calibration solutions and electrical components (Improved SD from 6 to 3). - Proactively led transition from a paper based DHF to an electronic DHF implemented in SAP. - Promoted to R&D Director, Instrument Development.

R&D Director, Software Instrumentation Laboratory Responsibilities - Led software development of our Hemostasis, Critical Care and Blood Gas products with focus on embedded and data management systems. - Designed and executed software development and product portfolio strategy. - Managed SQA, Software Test and Software Development groups comprised of 70+ FTEs including contractors and overseas resources. - Managed an annual budget of more than $8 million.

Accomplishments - Created new job descriptions for Software Test and Development and re-structured software department. - Designed mentoring, coaching and training programs to groom software group leads in order to accommodate management needs of our increasing project portfolio. - Directed software architecture and refactoring efforts to drive a platform approach to the development of new Critical Care and Blood Gas projects. Effort comprised application, embedded software and fluidic sequences. - Led creation and update of several standard operating procedures to harmonize and strengthen software engineering processes while establishing compliance with FDA Design Controls and SW Guidelines. - Led selection and harmonization of tools and processes across multiple sites (e.g. Requirements management, change management, configuration management, unit testing, static code analysis, coverage analysis, continuous integration, test automation, release management, documentation - Led creation of multiple software metrics and dashboards to unify reporting and tracking of key performance indicators (e.g. Burn down charts, trends, test case run rate, traceability, coverage, Defects/KLOC - Engaged consultants in the assessment of our software engineering processes and development of improvement plans (Increased test case run rate and schedule accuracy among other improvements). - Established internal audit program and procedures to drive software quality assurance. - Directed multiple SBC, PC and other computer obsolescence projects involving embedded electronics vendors (e.g. SECO, Ampro and consulting firms (e.g. Wind River, RedHat). - Led development and release of multiple instrument configurations targeting the Hemostasis and Blood Gas markets (5 instrument releases and multiple SW/parameters updates). - Led development and release of different data management solutions (6 commercial releases and multiple SW updates).

IVD SW Director Systelab Responsibilities - Managed two different business units - Analytical Systems SW and Data Management SW. - Managed a workforce of 20-30 FTEs and multiple project managers. - Designed and executed SW development and product portfolio strategy.

02/2009 to 01/2014 Bedford, MA

02/2007 to 02/2009 Lliça d'amunt, Barcelona / Spain

- Sought international partnership opportunities at both technical and distribution level. - Led SW development and SW Test process improvements. - Supervised accounts and all related project development activities. - Acted as SW Project Manager for the Hemostasis product line (ACL TOP).

Accomplishments - Led development and release of multiple instrument configurations targeting the Hemostasis market (3 instrument releases and multiple SW/Parameters updates). - Led development and release of the Instrumentation Laboratory website incorporating content management services for use by the different affiliates (www.instrumentationlaboratory.com).

SW Account Manager / SW Project Manager Systelab Responsibilities - Managed all projects developed within the scope of the Instrumentation Laboratory account. - Managed a workforce of 20-30 FTEs and multiple project managers. - Participated in corporate strategic and scientific advisory committee meetings. - Supported WW Business development activities (WW exhibitions and trade shows). - Elaborated project proposals to address the needs of our potential customers (Firm Fixed Price / Time & Material Based). Created budget proposals and tracked execution throughout the fiscal year. - Acted as SW Project Manager for the Hemostasis product line (ACL TOP).

Accomplishments - Led development and release of the industry leading ACL TOP Hemostasis analyzer followed by multiple SW/Parameters updates. Managed development and release of multiple software solutions and QA/QC services.

Academic Background

Master of Science: IT Management La Salle BCN

MBA: International Business Administration and Management La Salle BCN / Manhattan College

Bachelor of Science: Computer Science Universitat Gimbernat (Universitat Autonoma Barcelona)

Professional Courses and Certifications

Design Control: FDA Quality System Regulation AAMI

Coaching and Counseling for Outstanding Job Performance: Human Resources Development AMA

Green Belt Certification: Process Improvement SixSigma.us

Leadership and Management Development Certificate Program: Management Worcester Polytechnic Institute

Advance Problem Solving and Root Cause Analysis: Engineering Worcester Polytechnic Institute

Design Boot Camp: Computer Science Construx

Introduction to CMMi v1.2: SW Process Improvement Carnegie Mellon University

Software Development for Medical Device Manufacturers: Software Quality Software Quality Consulting, Inc

Project Management: Computer Science

12/2001 to 02/2007 Lliça d'amunt, Barcelona / Spain

2004 Barcelona, Barcelona, Spain

1999 Barcelona, Barcelona, Spain

1997 Sant Cugat del Vallès, MA, USA

2013 Boston, MA, USA

2013 Arlington/Washington DC, DC, USA

2011 Orlando, FL, USA

2011 Boston, MA, USA

2011 Boston, MA, USA

2011 Boston, MA, USA

2010 Pittsburgh, PA, USA

2008 Boston, MA, USA

2002

Asociacion de Tecnicos de Informatica (ATI)

Web Application Development Program: SW Development & Management Boston University

Barcelona, Barcelona, Spain

2001 Boston, MA, USA

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