Engineer Medical Device

NICOLE J. BOROUMAND

SUMMARY

Bilingual (English and Spanish) Quality and Regulatory Manager with over 10 years of international experience (in the USA and Spain) helping ensure medical devices and human cell manufacturing products meet regulatory, quality and customer standards. Award-winning public speaker with excellent written and verbal communication skills.

EDUCATION

March 2008

Master of Science in Mechanical Engineering – California Polytechnic State University

March 2008

Bachelor of Science in Mechanical Engineering – California Polytechnic State University

March 2012

Teaching Adult Learners Certificate – University of California San Diego Extension

July 2015

Executive Masters in Innovation – EOI Business School: Madrid, Spain

July 2017

Europe Quality Management Expert (ISO 9001) – Spanish Association for Quality

July 2018

Six Sigma Lean Black Belt Professional - Management and Strategy Institute

Expected: Dec. 2019

Regulatory Affairs Certificate: Medical Devices – Regulatory Affairs Professionals Society

WORK HISTORY

Oct. 2014 – Sept. 2019

Quality Manager, Aglaris Cell (Madrid, Spain)

·Launched an ISO 9001-based QMS from the ground up at 2 sites

·Developed organizational/product regulatory and quality strategies for human cell manufacturing products

·Authored organizational/quality SOPs

·Based on EU (CE Marking) and FDA (21 CFR) regulations

·Approved changes to test/validation procedures and SOPs

·Conducted internal audits at 2 sites and controlled vendor qualification

·Implemented company-wide training procedures, schedules, and evaluations

·Trained staff at 2 sites on quality, regulatory, and internal policies

·Prepared Gantt charts, employee tasks, materials, and equipment for various projects

·100% of deliverables submitted on time and below budget

·Led quality committee to execute numerous CAPAs and quality improvement initiatives

·Performed root cause analysis to identify operational issues

·Reformed Good Documentation Practices to reduce traceability incidents by 70%

·Developed organizational protocols to increase efficiency by 50%

·Measured and reported quality KPI status to site managers and C-suite executives

·Assisted with developing product specifications and non-conformance procedure

·Reviewed and approved manufacturing and QC records

·Wrote ISO 14871-based SOP on risk management and conducted risk assessments

·Wrote and planned project proposals. 3 project grants awarded

May 2017 - May 2019

Part-Time Instructor, Schiller International University (Madrid, Spain)

·College Math (MFG 1107): A mathematics and statistics course for business students

·Science and Society (SO 137): Science, technology, and ethics course for business students

Nov 2011 - Apr 2014

Test Engineer, L-3 Communications (San Diego, California)

·Managed project for a wearable multi-sensor concussion detection system

·Programed algorithm to reduce false positives by 72% from previous model

·Coordinated and conducted all Lot Acceptance Testing (LAT) for a sensor product line

·Gave presentations and submitted official government reports on test data

·Co-wrote project proposal which resulted in receiving a 15-million-dollar contract

·Assisted with managing patient database

·Improved testing procedures and designed test fixtures to reduce errors by 10%

Apr 2009 – Nov 2011

Associate Engineer, Reva Medical (San Diego, California)

·Improved QC practices to save time (30%), and reduce costs (20%)

·Designed manufacturing fixtures to improve pass rate from 60% to 95%

·Conducted international (Germany) supplier audits

·Developed in vitro model to test coronary stents which replicated in vivo results.

·Result: Reduction in the amount of animal testing performed

·Redesigned 100% of the packaging system, and performed sterilization testing 3 months ahead of schedule after an error was discovered to avoid clinical trial delays

Jan 2008 – Feb 2009

Associate Engineer, Xtent (Menlo Park, California)

·Prepared regulatory submissions to receive IDE FDA approval and CE marking certification for a class III medical device

·Designed low-profile (2.5 mm diameter) coronary stent delivery system

·Made technical drawings and Bill of Material for system

·Performed laboratory and pre-clinical testing on coronary stent delivery system

·Improved manufacturing process to increase pass rate from 25% to over 99%

Jun 2006 - Dec 2006

R&D Co-op, Advanced Bionics/ 9Boston Scientific (Valencia, California)

·Designed a minimally invasive surgical tool to implant spinal cord stimulation leads

·Collaborated with marketing to develop engineering specifications for a product accessory

July 2004 – Dec 2004

Research and Development Co-op, Alcon Laboratories (Irvine, California)

Developed fluidics and pressure sensing system for a low-cost portable cataract surgery machine to be used in developing countries

AWARDS

National (Spain) and international (Europe) Toastmasters public speaking champion

Graduate Equity Fellowship

Edwards Lifesciences Scholarship

Mazzetti & Associates Scholarship

First place Team Tech national competition for rollercoaster restrain system design

LEADERSHIP AND VOLUNTEER ACTIVITIES

Regulatory Affairs Professionals Society (RAPS) Member

American Society for Quality (ASQ) Member

Guest Lecturer at the Technical University of Madrid, Spain (Universidad Politécnica de Madrid)

Biannual master class on “Innovations in materials engineering to treat coronary artery disease” for 4th year and graduate students

Technovation: Conducted workshops for teenage girls in entrepreneurship and technology

President of Nova Communication Bilingual Toastmasters club

Outreach Education: Gave materials engineering workshops to middle school students

Raised $50K in Scholarships for the Society of Women Engineers

PUBLICATIONS

Juhas B.D.; Wong J.M.; Boroumand N.J.; Rigby P. H. (2013). Semi-Rigid Helmet Rotation Measurement Using Linear Accelerometers. ASME 2013 International Mechanical Engineering Congress and Exposition, Volume 3A: Biomedical and Biotechnology Engineering, doi:10.1115/IMECE2013-64677.

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