R D Director Instrument Development Resume Example

Love this resume?

By clicking Build Your Own Now, you agree to our Terms of Use and Privacy Policy

Jessica Claire
  • Montgomery Street, San Francisco, CA 94105
  • H: (555) 432-1000
  • C:
  • Date of Birth:
  • India:
  • :
  • single:

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).

I consider myself proactive, perseverant, open and constructive. I love working in team environments and building efficient teams by identifying talent, developing mentoring and coaching programs, empowering people and constantly grooming leads. Most importantly, I am a very passionate professional with a big sense of ownership that enjoys working hard and accomplishing challenging goals.

Lastly, I am a very logical, methodical and process oriented person with lots of common sense and practical vision. For this exact reason, and because I like well-structured processes and continuous improvement in general, I am trained in CMMi by SEI (Carnegie Mellon University), Lean Six Sigma and have experience improving processes using these and other methods.

  • 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
  • Design controls
  • Process:
  • 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
R&D Director, Instrument Development, 2014 to 10/2014
Instrumentation Laboratory City, STATE,


- 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 tradeoff 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).


- 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.

  • GEMWeb Plus: POCT Data Management solution. Linux, JBoss, PostgreSQL, J2EE, HTML5, HL7.
  • ProDx: Remote Diagnostics: PaaS, SQL Server, Windows, .Net, HTML5, Cloud, WAN, VPN.
  • HDMS: Hemostasis Data Management System: Windows/Linux, Oracle, J2EE, HL7.

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, 01/2009 to 2014
Instrumentation Laboratory City, STATE,

Main 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.


- 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).

- Directed development and release of multiple instrument configurations targeting the Hemostasis and Blood Gas markets (5 instrument releases and multiple SW/parameters updates).

  • Hemostasis Product Line (2): Windows Embedded, VxWorks, Nucleus, SQL Server, C++, .Net, STL, MFC, Boost, COM+, ClickOnce, ASTM/HL7, CANBus, FPGA, Microblaze, TheadX.
  • Critical Care Product Line (3): Linux, JBoss, PostgreSQL, J2EE, HTML5, HL7.

- Directed development of Data warehouse system to mine complaint and raw data

  • C#, WCF, WPF, SQL Server, ASP.Net, Winforms, SQL Integration Services (ETLs), SQL Reporting Services.

- Led development and release of different data management solutions (6 commercial releases and multiple SW updates).

IVD SW Director, 01/2007 to 01/2009
Systelab City, STATE,


- 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.

- 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).


- 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 (

  • Sitecore CMS,, C#, SQLServer.
SW Account Manager / SW Project Manager, 11/2001 to 01/2007
Systelab City, STATE,


- 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).


- 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.
  • Test Data Management System (TDMS): Software for automation of QC procedures intended for manufacturers of reagents and laboratory instruments. .Net, C#, SQL Server.
  • Linearity and Correlation Verification Software (LCVS): Statistical software for verification of Linearity, Performance, and Correlation of results for analytical instruments. Developed according CLSI (NCCLS) guidelines. Resulting in $373,375 cost savings / year. .Net, C#, SQL Server.
  • ISIWeb: Web platform to validate and calibrate medical devices. ISIWeb helps customers validate and assign ISI values locally (, C#, nHibernate, SQLServer.
  • QA/QC Projects: Software audits and independent verification and validation services (System test, static code analysis automation, tools validation, test automation…).

- Supervised development of ongoing data management projects

  • Impact: A MS Windows-based Data Management System for Critical Care instruments.
  • GEMweb Plus: A Linux-based Data Management System for Critical Care instruments.
  • Middleware Applications: SW solutions to enable connectivity between instrumentation, data management and other information systems (LIS, HIS).
Academic Background
Master of Science: IT Management, Expected in 2004
La Salle BCN - Barcelona, Barcelona
MBA: International Business Administration and Management, Expected in 1999
La Salle BCN / Manhattan College - Barcelona, Barcelona
Bachelor of Science: Computer Science, Expected in 1997
Universitat Gimbernat (Universitat Autonoma Barcelona) - Sant Cugat del Vallès, MA
Professional Courses and Certifications
Design Control: FDA Quality System Regulation, Expected in 2013
AAMI - Boston, MA
Coaching and Counseling for Outstanding Job Performance: Human Resources Development, Expected in 2013
AMA - Arlington/Washington DC, DC
Green Belt Certification: Process Improvement, Expected in 2011
to - Orlando, FL
Leadership and Management Development Certificate Program: Management, Expected in 2011
Worcester Polytechnic Institute - Boston, MA
Advance Problem Solving and Root Cause Analysis: Engineering, Expected in 2011
Worcester Polytechnic Institute - Boston, MA
Design Boot Camp: Computer Science, Expected in 2011
Construx - Boston, MA
Introduction to CMMi v1.2: SW Process Improvement, Expected in 2010
Carnegie Mellon University - Pittsburgh, PA
Software Development for Medical Device Manufacturers : Software Quality, Expected in 2008
Software Quality Consulting, Inc - Boston, MA
Web Application Development with ASP.Net 2.0: Computer Science, Expected in 2006
Netmind - Barcelona, Barcelona
Windows Application Development with .Net: Computer Science, Expected in 2004
New Horizons - Barcelona, Barcelona
Project Management: Computer Science, Expected in 2002
Asociacion de Tecnicos de Informatica (ATI) - Barcelona, Barcelona
Web Application Development Program: SW Development & Management, Expected in 2001
Boston University - Boston, MA

By clicking Build Your Own Now, you agree to our Terms of Use and Privacy Policy

Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.

How this resume score could be improved?

Many factors go into creating a strong resume. Here are a few tweaks that could improve the score of this resume:


Resume Strength

  • Measurable Results
  • Personalization
  • Target Job

Resume Overview

School Attended
  • La Salle BCN
  • La Salle BCN / Manhattan College
  • Universitat Gimbernat (Universitat Autonoma Barcelona)
Job Titles Held:
  • R&D Director, Instrument Development
  • R&D Director, Software
  • IVD SW Director
  • SW Account Manager / SW Project Manager
  • Master of Science
  • MBA
  • Bachelor of Science

Similar Resume

View All
Instrument and Control Superintendent
Principle Instrument and Control System Engineer