Jay Dave

**** ***** *****, ********, ** *****

Cell: 760-***-**** Email: actg84@r.postjobfree.com

Executive Summary

Result oriented executive and strategic management professional with more than 10 years of product development and executive leadership experience. Proven track record of building and managing highly productive and skilled teams. Strong leadership, strategic-planning and people-management skills. Transforms high-potential staff into outstanding technical leaders who demonstrate the creativity and innovation that is critical to organization success.

Core Qualification

Cross-functional team management

Technology & Market analysis

Business development

Time & Resource optimization

Portfolio planning & Strategic management

Program & project management

Lean product development

New product development and life cycle management

Medical device software development (IEC 62304)

Risk management (ISO 14971)

Usability engineering (IEC 62366)

Quality management system (ISO 13485)

Analog and Digital circuit design

Problem solving (Toyota A3)

Professional experience

Director, Product Development

August 2012 to Current

DJO Global LLC, Vista, CA

Lead domestic recovery science business unit ($400 million in revenue) engineering team which specializes in product development with direct impact on overall objectives of the company

Define product development strategy and product portfolio to achieve strategic initiative to achieve 8% revenue from new products every year

Created strategic vision "SmartCare" to accommodate "Affordable care act" changes and initiated design of future generation platform system and products to manage care through life cycle of episode, treatment protocols, electronic medical records (EMR) and bill information

Established new product introduction procedures and policies for FDA and other regulatory bodies design guidelines, which impact the broader development

Provide fostering environment for team members to be productive and have higher engagement

Determine how to best utilize resources and budget to complete project and department objectives

Provide leadership, work direction and guidance to the group and interacts frequently with external clients and cross functional managers at all levels to achieve overall business objectives

Engineering Project Manager

March 2010 to August 2012

DJO Global LLC, Vista, CA

Managed multiple product development projects(annual revenue from $500k to $5 million) through it life cycle from project initialization to market release and provide support to post market activities

Designed, supported and managed complex home and clinical rehabilitation products (Diathermy, laser, ultrasound, electronic muscle stimulation. electromyography) under DJO, EMPI and Chattanooga brand names

Established company wise "Risk Management System" and procedure to comply with ISO14971:2007 and 2012 standards

Established company wise software design, verification and validation system and procedure to create better system to comply with FDA and international regulatory software and hardware development requirements such as IEC 62304 standards for software life cycle

Worked with outside testing agencies to provide gap analysis and defined testing requirement to comply with IEC 60601-1 (medical device safety standard) 3rd edition

Senior Electrical Engineer

January 2007 to March 2010

DJO Global LLC, Vista, CA

Designed and Developed for hardware and software design of next generation prophylaxis device for Deep Vein Thrombosis (Aircast Venaflow Elite)

Documented software and hardware design for domestic and international compliance

Monitored and managed internal and external verification and validation activities

Tested device for IEC60601-1, IEC60601-1-2, IEC60601-1-4 and IEC60601-1-6

Designed automated self diagnostic and data collection system for inline production testing

Spearheaded products and technical knowledge transfer during Chattanooga group acquisition

Electrical Engineer

July 2003 to January 2007

Genefluidics Inc, Irwindale, CA

Designed potentio-state circuit for molecular detection using proprietary Genefluidics three lead electro-chemical electrodes using extremely low level current detection (nA and µA), high speed close loop amplifier and error amplifier circuits

Designed multichannel data acquisition system with 16 channel simultaneous channels sampling 24-bits data at 600 Hz

Developed system control firmware and computer software to control and display real-time data for 16 channel data acquisition system

Developed fully automate delivery system for bio-samples and chemicals to electro-chemical electrodes

Tested device for IEC60601-1 and IEC60601-1-2 standards

Education

Executive MBA, 2013

San Diego State University, San Diego, CA

Master of Science, Electrical Engineering, 2003

University of Southern California, Los Angeles, CA

Bachelor of Science, Electrical Engineering (Instrumentation and Control Engineering), 2001

Gujarat University, Gujarat, INDIA

Graduate Certificate, Strategic Management, 2014

University of California San Diego, San Diego, CA

Graduate Certificate, Project Management and System Engineering, 2006

University of California Los Angeles, Los Angeles, CA

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