Elan Elvaiah

(***) ***-Elan • acch41@r.postjobfree.com • San Diego, CA 92109

LinkedIn: http://www.linkedin.com/in/elanelvaiah

~ SUMMARY OF QUALIFICATIONS ~

** ***** ********** ** *** healthcare, diagnostics, and medical device industries with focus on customer

service, product management, field service, patient care, and research and development.

Demonstrated success in product support, troubleshooting, and implementation of new standards,

procedures and guidelines while maintaining quality assurance.

Strong organizational, analytical, and interpersonal skills with customer service as top priority.

Accomplished in managing team of engineers and providing training and support.

Fluent in English and Hebrew.

~ COMPETENCIES ~

Customer Service Problem Solving

Field Applications & Support

Coordination & Collaboration Project Management Software/Hardware Support

FDA & ISO Regulations

Training Research & Development

~ PROFESSIONAL EXPERIENCE ~

Sales Engineer Jan 2013 to Aug 2013

MadCap Software, San Diego, CA

- Provide technical assistance on MadCap products to the sales team

- Conduct remote client meetings; primarily in the form of product demonstrations

- Present new product features and functionality to internal and external customers

- Attend and represent MadCap at various industry tradeshows and events

- Assist in completion of client Request for Proposals or Request for Information

- Liaise between customers and the development team in reporting product feature requests

Project Engineer 2010 to 2012

Hologic / Gen-Probe, San Diego, CA

Oversaw collaboration of stake owners in the development of service support documentation and new electronic

delivery systems to support sales & marketing groups, field service engineers, and distributors in the EU & US areas.

- Act as key point person in the development of service manuals, field service notifications, and

troubleshooting guides for high throughput molecular diagnostics instrument.

- Coordinate with marketing & sales, technical training, and product application groups for beta trials,

clinical studies, and EU & US launches.

- Facilitate interdepartmental communication regarding projects and develop cutting edge technology

platforms for support.

- Participate in software validation and verification process, installation for remote diagnostics, site

preparation, LIS systems, white paper marketing, and CRM databases.

Applications Specialist 2008 to 2009

Cyntellect, San Diego, CA

Tested and prepared overall readiness of instruments for marketing & sales demonstrations, tradeshow and customer

service trainings.

- Provided product support for development, installation, and servicing of optical-based electromechanical

instrumentation, used for cell-based life science applications.

- Implemented human factor engineering for instrument’s hardware/software development, validation and

verification activities, calibration, and alignment of optical and mechanical systems.

- Aided in product setup to sales and marketing representatives for customer trainings, demos, and trade

shows.

Lead Field Service Engineer 2007 to 2008

Cardinal Health, San Diego, CA

Participated in a company wide upgrade to all Cardinal Health US client hospital and clinic’s infusion pumps.

Responsible for delivering quick turnaround and an emphasis on customer service for my designated sites.

- Lead FDA remediation field engineer upgrading medical infusion pumps used in hospitals; managed

work flow, instrument upgrade, and training to medical staff.

- Mentored and managed team of field service engineers and provided training on instrument.

- Maintained equipment summaries, weekly logs, expense reports, project plan, and ordering of supplies.

Senior Validation Engineer 2005 to 2007

Althea Technologies, Inc., San Diego, CA

Was responsible for the coordination and execution of the facility’s on-going daily validation efforts. Supervised

vendors’ validation activates (in accordance with client’s requirements) for a specific gene hormone enhancement

technology to be used in a Phase III clinical trial development.

- Developed and implemented new standards, procedures, and guidelines for customer’s product

development.

- Management and execution of department’s validation activities. Provided leadership in devising strategy for

implementation of the biotechnological facility and equipment (validation master plan).

- Assisted in audits and performing QA activities such as: initiating deviations, change controls, and reviewing QA

documents.

Project Manager 2002 to 2005

Soroka Hospital, Beer Sheva, Israel

Roll out of a new respiratory device for the hospital’s ENT department. Developed and nurtured strong relationships

with patients, nurses, and doctors utilizing the department’s diagnostic device.

- Managed ENT development project of a diagnostic respiratory device that determines patient nasal

resistances.

- Assisted in clinical trial testing and market research; analyzed and interpreted respiratory curves to

determine best patient outcome.

- Guided new device development of software and hardware while ensuring quality control.

- Training to the medical staff on device’s GUI and relay of feedback to the R&D teams.

~ EDUCATION & TRAINING ~

Master of Science, Biomedical Engineering

Ben-Gurion University, Beer Sheva, Israel

Bachelor of Arts, Computer Science

Tel-Hai College, Kiryat-Shemona, Israel

Armed Forces: Israeli Defense Force (IDF), Artillery Fighting Unit

Technical Communications Expert, First Sergeant, 1995 to 1998.

~ TECHNICAL COMPETENCIES ~

Operating Systems: Windows 95/98/NT/2000/XP, UNIX

Protocols: IO/OQ/PQ

Applications: C, C++, Java, Photoshop, MS Project, Visual Basic, Assembler, MS Office (Word/Excel,

PowerPoint, Access, Outlook), LabVIEW, MATLAB, STATGRAPHICS, FrontPage, SAP, Oracle.

~ PUBLICATIONS ~

“An Improved Device for Posterior Rhinomanometry to Measure Nasal Resistance”, Journal of Biomechanical

Engineering, November 2005

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