1. Sami Ali Helou 6375 Greenfield Rd. #1510
Elkridge, MD 21075
yahelou@gmail.com Cell: 901-283-3457
EXPERIENCE
ACell, Inc, Columbia, MD August 2014 – Present
Product Development Engineer II
 Lead project on Urinary Bladder Matrix (UBM)-based devices developed for Temporomandibular joint (TMJ)
and Whipple Procedures
o Prototyped a variety of test samples and created multiple manufacturing techniques
o Developed new test protocols to characterize devices
o Assisted with obtaining Voice of Customer from Physicians
o Accustomed to IDE and PMA submissions
o Completed documentation for multiple Design Control Phases in accordance with ISO 13485
 Drafted necessary DHF documents needed to complete line extension on existing product
 Developed a prototype UBM-based foam and created test protocols for material characterization
 Lead project in finding more efficient equipment for manufacturing UBM-based powder
 Assisted with DHF compilation and closure of Audit reviews
 Drafted an investigational study to improve the Endotoxin Testing SOP being used at ACell manufacturing
facilities
 Conducted academic collaborations for pre-clinical studies for evaluation of UBM based devices
 Wrote multiple documents for a new measurement system implemented within R&D lab:
o Test Method Validation
o Standard Operating Procedure
o Preventative Maintenance
o Installation/Operational Qualification
Olympus Medical, Memphis, TN October 2010 – August 2014
Product Development Engineer I (Oct. 2011 – Aug. 2014)
 Project lead on chitosan-based technology for ENT (ear, nose, and throat) surgeons
o Prototyping of different wound healing mediums that are biocompatible and degradable for the sinus
o Help identify important formulation factors through design of experiments
o Coordinate surgeon review panels
 Development engineer for DTAD; Released in 2013, DTAD is the first fully disposable and stand-alone
debrider for tonsillectomy and adenoidectomy
o Responsibilities dating from feasibility stage to post-launch support; delivery dates and cost of goods
were on target
o Experience with:
-Plastic injection molding
-Overmolding of thermoplastic elastomers
-Monopolar/bipolar electrosurgery
-Induction/ultrasonic welding
-DC/AC electric motors
-Solvent bonding of plastics
-Hipot testing with bronze, nitinol, titanium, and
stainless steel materials
 Development engineer for cost savings project on multiple legacy lineups of debrider/burr blades
o Experience with: halar/chrome coating, electropolish, Electric discharge machining (EDM), laser
welding/cutting, unique 3-layer torque coil designs, burr tips
Product Development Intern (Oct. 2010 - Oct. 2011)
 Assisted R&D drafter with multiple CAD projects
 Assisted in compiling Design History File by creating Risk/Hazard Analysis, FMEA, Risk Considerations, &
Product Performance Specifications
 Experienced with Change Orders, Process Control & Validation, Quality Management Systems, & IQ/OQ
 Assisted with multiple proprietary projects including electrosurgical blades & otology implants
Wright Medical Technology, Arlington, TN August 2009 – September 2010
Regulatory Affairs Intern
 Became well-acquainted with ISO 13485
 Updated Design Control documentations with R&D
 Compiled submission work including: 510(k) submissions for the U.S. & CE Marking for Class II & Class III
devices in the orthopedic industry (MIIG X3 injectable graft, ADVANCE knee system, OSTEOSET pellets)
 Project lead for the creation of a database of all product codes & standards
 Worked on smaller projects involving checking engineering drawings for accurate tolerances, Verification &
Validation documents, & summarization/analysis of clinical studies

2. University of Memphis, Memphis, TN Spring 2009
Graduate Assistant
 Worked on multiple projects involving polymers, such as chitosan
 Operated multiple equipment such as High Performance Liquid Chromatography, Instron, X-Ray Diffraction,
Fourier Transform Infrared Spectroscopy, & Scanning Electron Microscope
EDUCATION
University of Memphis, Memphis, TN August 2008 – May 2011
▪ MS Biomedical Engineering GPA: 3.66/4.0
▪ Thesis title: Evaluating elution & mechanical characteristics of a calcium sulfate bone graft substitute
containing amphotericin B, cefazolin, or vancomycin
Christian Brothers University, Memphis, TN August 2004 – May 2008
▪ BS Biology GPA: 3.45/4.0
SKILLS
Experience in programs such as Solidworks (Modeling/Drawing, Motion, Simulation), COSMOS, LabVIEW,
Minitab; Several R&D analytical/characterization equipment including Instron, Scanning Electron Microscope
(SEM), Differential Scanning Calorimetry (DSC), Particle Size Analyzer.
References upon Request