. Focused leader with extensive experience in the area of Quality
Assurance, and Manufacturing. Expert in building highly effective
teams to help the organization in delivering world-class medical
device products to market.
. Leadership: Various leadership roles in the area of Quality
Assurance / Manufacturing with the main focus of establishing
processes and operating policies to contribute in shortening product
development life cycle, maximizing efficiency and productivity of
the departments; managing over 75 headcounts.
. Organizational Excellence: Highly skilled in budget planning,
assessment of personnel needs and hiring of top notch human
resources for the department and training of personnel to be updated
with the latest tools to maximize the productivity of the
. Worked as a team with various functional disciplines such as Electrical /
Mechanical Development, Test Engineering (ATE), Manufacturing, and
. Heavily involved with Contract Manufacturers globally (ex: Malaysia,
. Head of Quality Assurance Engineering for implantable products.
Responsible for internal audit, ensuring compliance to company
procedures. Flagged and addressed compliance issues.
. Head of Software Quality Engineering organization to support the
verification and validation of implantable and external products.
. Member of Product Improvement Board as part of the CAPA system
. Highly knowledgeable in medical device regulations,
ISO9001/ISO13485, and the Medical Device Directive (MDD) in addition
to submission material for gaining FDA and T V approvals.
St. Jude Medical, Cardiac Rhythm Management Division
Manager, Design Assurance (Oct 2000 to Jan 2013)
. Established procedures, processes, and operating policies in the
area Software Verification and Validation. Led process improvement
initiatives for streamlining system definition, risk analysis,
integration, and validation activities.
. Performed internal audit making sure compliance to company
procedures and outside regulatory requirements.
. Contributed in shortening product development life cycle, maximizing
efficiency and productivity of the departments, while supporting the
day to day activities of production and manufacturing.
. Skilled in budget planning, assessment of personnel needs, and
hiring of top notch human resources for the department. Established
and structured programs in training of personnel, and updating them
with the latest tools to maximize productivity of the department.
. Head of Design Assurance to support implementation of automated
manufacturing and other business related systems.
. Six Sigma Champion and Green Belt certified with extensive knowledge
of DFSS and Lean methodologies.
. Group leader for integration of acquired entities. Direct
involvement with Global Contract Manufacturers in India, China,
Malaysia, Sweden, and Puerto Rico.
Manager, Software Quality Assurance (Oct 1993 to Oct 2000)
. Responsible for the validation, control, and distribution of class
III medical product software (implantable Pacemakers, and
implantable defibrillator), and all manufacturing test software.
. Developed, documented, and implemented improved software validation
processes and documentation system in accordance with the FDA
. Set guidelines for development of Requirements Specification, Design
Specification, Issue Tracking, and Configuration Management.
. Established an audit program for QA department on off-the-shelf
software or custom software developed by third party.
. Developed a corporate wide software development policy to shorten
the development life cycle and streamline the validation activities.
. Implemented automated software test systems to improve the testing
capabilities and shorten the test time.
Sr. Software Quality Assurance Engineer (Mar 1989 to Oct 1993)
. Responsible for validation of automated test software utilized in in-
process and final testing of cardiac pacemakers and its components
such as LSIs and Hybrid assemblies.
. Review of software requirement specification, design specification,
and code walk-through.
. Developed Software Validation Plans (SVP) based on requirement
specification. Designed test cases for each requirement in the SVP
with inclusion of specific test procedures and acceptance criteria.
. Performed extensive static and dynamic testing and developed
Software Validation Reports (SVR) to report the results of the
. Evaluated changes to the software to determine validation activity
against the changes such as limited validation or regression
. Performed Software risk and hazard analysis to determine criticality
of certain modules.
. Utilized issue-tracking system such as DCS, to report software
issues and assuring that corrective action gets in place to resolve
. Responsible for developing automated test systems for testing
pacemaker products and components such as LSI and hybrid assemblies
using various types of test stations.
. Designed test fixture for interfacing purposes.
. Trouble shooting test station and deploying test system to vendors
. Responsible for testing of implantable and external drug pump.
. Performed fault isolation activities for assemblies in WIP.
. Trouble shooting assemblies to the component level, generated
reports and recommended corrective action for product improvement
Education & Training
. CALIFORNIA STATE UNIVERSITY, FRESNO, BS Electrical Engineering
. Management in Manufacturing - UCLA