Medical Device Engineer

R&D · Product Development & Sustaining · Manufacturing · Design Control

Summary of Qualifications

Five years of experience leading all aspects of design to strategically position medical devices for regulatory clearance.

Professional Experience

Alcon Laboratories, Irvine, California                                                                                                           Apr 2018 – Oct 2019

Technical Transfer Engineer, Manufacturing, Science, & Technology

o   Successfully gained market release for the manufacturing process of a cataract surgical handpiece representing $30M in yearly sales

–  Proactive ownership of tasks contributed to the process verification of new product

–  Developed new process assembly procedures using learned product knowledge

–  Facilitated incorporation of test builds into day-to-day production activities

–  Planning of project resources with direct reporting of concerns to management

–  Conceptualized, designed, and validated test fixtures and equipment

·       Modified and/or authored FMEAs and test methods to support fixture qualification(s)

–  Investigated potential process improvements and analyzed implementation performance

–  Participated in root cause investigation through the use of problem-solving tools

·       Characterized the impact of production fixtures on products

–  Processed change requests and coached new hire(s) into supporting tech transfer role

Edwards Lifesciences, Irvine, California

Jan 2016 – Jan 2018

Sustaining R&D Engineer, Critical Care Operations

o   Supported the verification and validation activities of a high-impact $6.3M sterilization conversion project for invasive disposable plastic products

o   Created a leverageable reference repository that captured variations used to create over 700 finished goods leading to reduction of biocompatibility testing and the anticipated reduction in the time to market for future development activities

§  Structured a novel biocompatibility submission process using in-depth product knowledge

§  Served as subject matter expert (SME) to train and guide peers to execute novel process

§  Acted as a liaison between Edwards and the North American Science Associates, Inc. (NAMSA) by providing technical expertise to ensure conformance with ISO 10993

o   Key figurehead in multidisciplinary product development activities including:

§  Generation of the project plan, scope, and purpose

§  Development and execution of project deliverables with cross-functional input

§  Met project deadlines by coordinating activities with internal & external laboratories

§  Guided proper project execution by generating test method validations, fixturing, first article reports and associated standard operating procedures

§  Implemented GDP using internal documentation software (Ignite product lifecycle management software) and assisted/trained others

§  Strategized collaborative approvals of reports using properly executed statistical approaches in Excel and Minitab including distribution fitting, CpK/PpK, tolerance limits, etc.

o   Interfaced directly with offsite manufacturing facilities in the Dominican Republic (DR) to control accuracy of sample builds, testing and other activities

o   Assisted DR team with process validation activities

o   Initiated performance testing for intravascular catheters per internal requirements and ISO 10555 to support DHF

o   Developed design control documentation for the Swan-Ganz family of catheters

Edwards Lifesciences, Irvine, California                                                                                                            Mar 2014 – Jan 2016

Intern to R&D Engineer, Critical Care NPD

o   Generated evidence that pressure monitoring products complied with ISO regulations and internal design controls to support regulatory certifications

o   Facilitated disposable pressure transducer testing per AAMI BP22 and IEC 60601

o   Proactively led risk assessment of product failures and achieved corrective action resolution with external suppliers

o   Worked with an external vendor to execute surface area calculations for biocompatibility studies using Excel and generic surface area equations

o   Enhanced surface area calculations for biocompatibility studies by creating Solidworks parts which a led to reduction in costs for future submissions

o   Assisted with the development of new blood sampling device by creating CAD designs for tools and jigs per company standards and AMSE/ANSI

NMT II, Fountain Valley, California                                                                                                           Jun 2013 – Sept 2013

R&D Engineer

o   Continued development of mitral valve plication device (refer to UCI Capstone Project below)

o   Initiated and completed engineering change documentation for product and/or part changes using SolidWorks and AutoCAD

o   Trained in a system compliant with FDA and ISO quality system regulations (21 CFR & ISO 13495)

Other Applicable Experiences

10+ years as fire sprinkler design technician                                                                                                           Jun 1997 – Sept 2013

Education

Keck Graduate Institute, Claremont, California                                                                                                           Aug 2016 – May 2017

Certificate, Regulatory Science

Problem Based Project

1.     Participated in-class project to create a point-of-care diagnostic device to measure digoxin

2.     Helped formulate physical mechanics and identify hardware to carry out a cross-functional assay

3.     Participated in team ideation to agree on hardware solutions modeled for presentations and reports

 

University of Southern California, Los Angeles, California                                                                                                           Aug 2013 – Aug 2015

Master’s of Science, Electrical Engineering

Graduate Capstone Project

1.     Worked with a mentor to develop a project concept focused on ambulatory blood measurement

2.     Formed a team of three that developed an algorithm to estimate and display blood pressure on an Android device by using EKG datum to time digital plethysmography signal.

3.     The team successfully defined problem, researched previous technologies to generate concepts, developed system design and algorithm, and merged conflicting communication standards

4.     Implemented Bluetooth or Bluetooth Low Energy standards for signal transmission

5.     Presented findings to panels at USC and Edwards Lifesciences

University of California, Irvine, Irvine, California                                                                                                          Sept 2010 – Sept 2013

Bachelor’s of Science, Biomedical Engineering

Undergraduate Capstone Project

1.     Studied heart anatomy, mitral valve regurgitation (MR) correctional procedures, and devices involved with MR catheter procedures

2.     As a team, developed a minimally invasive suturing device to perform mitral valve annuloplasty for patients suffering from mitral valve regurgitation

3.     Members were responsible for ideation which was subject to a collaborative team down-selection process for integrating the various functions of the device

4.     Designed the distal end to integrate with functions at the proximal end of the device

5.     Successfully integrated five degrees of freedom into three buttons using a telescoping design

6.     Managed Solidworks modeling process for components, assembly, and fabrication of a 10X SLA prototype to analyze device function and fitting

7.     Received training from senior management of Edwards Lifesciences to develop leadership style and teamwork skills in a project environment

8.     Leveraged the project to gain employment working within the mentoring company (refer to Nobles Medical Technology II in Employment Section below)

Los Angeles Valley College, Valley Glen, California                                                                                                           Aug 2007 – June 2010

Associate’s of Science, Physics

Skills

  • Anatomy
  • AutoCAD
  • Creo
  • Design Control
  • FDA
  • Fixturing
  • Microsoft Office suite
  • Pathology
  • Physiology
  • Process Validation
  • Product Lifecycle Management
  • Quality System
  • SolidWorks
  • Technical Writing
  • Tooling
  • Verification & Validation

Education

Aug 2013-Aug 2015

Electrical Engineering at University of Southern California

Sept 2010-Sept 2013

Biomedical Engineering at University of California, Irvine

  • Updated 7 months ago

To contact this candidate email abds@usa.net

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