1. 23705 Lincoln Avenue
Murrieta, CA 92561
Cell: 951-452-3380
eva.harding@av.abbott.com
EvaM.Harding
Objective
To enhance my professional career by expanding on leadership responsibilities,
learning the business model and strategically making decisions, thus enabling me to
lead the organization in meeting and exceeding its corporate goals.
Medical
Device
Experience
August 2011 – Present Abbott Vascular Temecula, CA
Sr. Quality Engineer – AVIC
 Supported multiple medical device development programs including bare metal and
polymer guidewires and bare metal, drug eluding and bioresorbable stent systems
through design controls phase reviews and submissions including the following
deliverables:
- Risk Assessment Matrix Reports (Process, Design, Component and Use FMEA)
- Filing and Aging Protocols and Reports
- Test Method Validation (MSA, SFU, RA)
- Human Factors Engineering
- External Requirements Compliance and conformity
- Inspection Plans
- Validation Master Plan
- CE and US Submissions
April 2010 – August 2011 Abbott Vascular Temecula, CA
Sr. Product Performance Engineer
 Provided timely, accurate & compliant data request for Audits, regulatory inquiries,
Business Units’ inquiries, corrective action activities (CAPA's, audit responses, etc.),
product development (RAM development, needs assessments, etc.), investigations for
marketing or management inquiries, and other activities.
 Supported the application/interpretation of data for Dilatation and Bare Metal Stent
products; presented monthly CAPA reports to Business Units. Elevated compliance risks
and procedural deficiencies provided thorough investigations and identified potential
deficiencies in manufacturing or product use.
March 2008 – April 2010 Abbott Vascular Temecula, CA
Sr. Quality Engineer – Implant NPD
 Supported BVS implant test method development and validation; Thinman equipment
and RM development; Racer Risk Assessment; Xience Nano PMA submission
- QE support for the successful production of Thinman implant GLP builds meeting
accelerated timeline and bonusable milestone. Brought Santa Clara implant materials,
equipment and documentation to N lot manufacturing capability.
- Developed Thinman implant Design and Component FMEAs and facilitated Risk
Review Board meeting and gained Phase 1 RAM approval.
- QE responsible for Thinman process equipment specifications and equipment
compliance documentation including User Requirements Specifications (URS) and
Risk Assessment (RA) development for Pico-Second Laser, Automated Wetbench
and Heat Treatment System (annealing oven).
- Supported feasibility, PQs, cleaning validations and stability studies on Nitinol, Co-Cr
and SS process chemicals successfully meeting CAPA deadline.
- Oversaw successful Summer intern project to characterize Co-Cr electropolish life
cycle .

2. Eva Harding Page 2 of 3
November 2005 – March 2008 Guidant Corp/ Abbott Temecula, CA
Process Quality Engineer - Implants
 Supported assessment of new Co-Cr hypotubes supplier per DOP205 for OQ and PQ
studies; cooridinated alginment study between Abbott RI testing and new supplier.
 Optimized and aligned raw material requirements for electropolishing chemicals
including CR for vendor process change and specification clarification which aligned
multiple outside vendors and test laboratories to correct specification.
 Worked on all Pathfinder implant process development including successful GLP builds,
POC and OQ/PQs.
 Lead CAPA investigation for hypotube mechanical property lot failures including
discovery of inadvertently release of lots with test failures.
 Validated and brought on line new mechanical pull test machine (Tinius Olsen) including
round robin test method alignment with hypotube supplier certification testing.
 Responsible for Implant portion of device Risk Assessment for Jaguar (Xience Prime)
and Pathfinder (SBA)
2004 – 2005 Desert Cardiology Center Rancho Mirage, CA
Research Coordinator
 Worked with Site Coordinator and Primary Investigators to facilitate clinical research
trials for cardiac drug therapies and medical devices, including pacemakers,
defibrillators and stents.
 (Enrique Jacome M.D., Inc ) Responsible for all aspects of research study including
obtaining patient consents, researching patient history for inclusion/exclusion criteria,
completing Case Reort Forms (CRFs), maintaining accurate database and source
documentation, and Institutional Review Board (IRB) submissions.
 Developed site specific Standard Operating Procedures (SOPs) maintaining site
compliance with state and federal regulations, including implementation of Good
Clinical Practices (GCP)
Engineering
and Program/
Project
Management
Experience
2001 – 2002 Armtec Defense Products, Inc. Coachella, CA
Program Engineer
 Responsible for highly visible artillery program projects, worked with program
manager to coordinate and execute special development projects for the U.S. Army
1996 – 2001 Alliant Tech Systems, Inc. Radford, VA
Program Manager of Artillery Program (1999-2001)
 Managed multi-million dollar U.S. government contract for artillery solid propellants
Program Engineer (1998-99)
 Responsible for preparation and presentation of all artillery propellant proposals
 Tracked program /project quality, cost and schedule, identifying means for
continuous improvement of product and process
Process Engineer (1997-98)
 Optimized solvent-based manufacturing processes for artillery propellants
 Implemented process controls, specifically addressing extrusion parameters to
maintain product dimensional uniformity
 Coordinated installation and operation of NitRem Pilot plant for DNT/TNT
wastewater destruction

3. Eva Harding Page 3 of 3
1995-1996 Olver Inc Blacksburg, VA
Project Engineer, Environmental Consulting
 Performed Safety Training to employees at firm
 Assisted with site remediation for ground water and soil contamination projects
 Performed Hazardous Operation analysis
1989-1994 The Goodyear Tire and Rubber Co Akron, OH
Management Training Program for Chemical Engineers
Participated in a rotational program working year assignments in marketing, process
engineering, manufacturing and R&D.
Education University of Virginia Charlottesville, VA
 Bachelor of Science, Chemical Engineering
Summer Work Exchange Program 1987 Gothenburg, Sweden
 Engineering Design at Volvo Lastvagner AM
 Analytical Methods at Astra Meditech
Certificates
 The Institute for Therapy Advancement/ North America “Basic Concepts of
Implantable Device Therapy” - Guidant Corp.
 National Institute of Health (NIH) Certificate of Completion “Human Participant
Protections Education for Research Trials”