CAREER OBJECTIVE

A full-time career in product development, validation and testing of disposable products for diagnostic and therapeutic medical devices and equipment, leveraging my 10+ years of industry experience

EDUCATION

Master of Engineering, Mechanical Engineering 2005

McGill University, Montreal, QC, Canada

Bachelor of Engineering, Mechanical Engineering 2000

Bangalore University, Bangalore, Karnataka, India

SUMMARY OF QUALIFICATIONS

• Linguistic Fluency (oral and written): English, French, and Hindi

• Experience in Project management of blood contacting disposable medical devices and heavy machinery

• Experience in developing Design History Files (DHFs) per CE Mark, FDA and ISO13485 regulations

• Experience with electronic device maintenance and data acquisition and proof-of-concept testing

• Experience with thermal (electronics packaging) and structural (tip-over, static loading) analysis software

• Three years experience in designing and testing high grade plastic injection molded components

• Three years experience in medical device research in cardiovascular, dialysis, oncology and critical care

• Three years experience in product development of heavy equipment and aircraft simulators

COMPUTER SKILLS

• Working knowledge of Microsoft Project, MS Excel, MS Word, Minitab, MATLAB, and LabVIEW

• Proficiency in:

o SolidWorks 2010

o Unigraphics NX5 and NX6

o NX Thermal and Flow solvers

o FEMAP 9.3

o AutoCAD

o Pro/INTRALINK

o Pro/Engineer 2001 and Wildfire 2.0

o Pro/Mechanica

o CorelDraw

o ANSYS

o MathCAD

o PDMWorks

WORK EXPERIENCE

Project Engineer 2010 - 2011

Bavaria Medical Technologies Canada Inc., Montreal, QC, Canada

o Established Proof-Of Concept metrics for a new minimally invasive device for PAVR

o Designed an experimental test rig using load sensor and actuators to test cutting efficiency of blades

o Used MATLAB and LabVIEW to process data acquired from experimental testing of prototypes

o Tested and calibrated new components and measurement systems in keeping with ISO13485

o Created SOPs and test instructions for new product development per ISO 13485 and CE mark guidelines

o Designed, prototyped and tested injection molded and extruded plastic, and machined metal components

o Generated assembly and inspection instructions for catheter tubing using tolerance analysis and GD&T

o Generated material defect criteria for multi-lumen and co-extrusions and injection molded devices

R&D Engineer 2008 - 2010

CardioMed Supplies Inc., Lindsay, ON, Canada

o Designed and evaluated sterile injection molded or extruded disposable medical devices (blood and urine bags, BCN holders) and Dialysis, PICC, CVC and IV catheters (Silicone, PVC, TPU) and IV lines using AutoCAD 2010 (2D detailing) and SolidWorks 2010 (3D modeling and Detailing)

o Setup an assembly line and created assembly instructions and DHFs for manufacturing disposable quick release holders for a blood collection needle (DROP-IT) and an extracorporeal blood filter (ULTRAFIL)

o Reduced inventory cost for hemodialysis and peritoneal dialysis disposables through vendor negotiations

o Maintained electronic packaging machinery, burst testers, pull testers and measurement gauges

o Created and improved work, calibration, and test instructions for new products, measurement systems and electromechanical packaging systems respectively per ISO 13485

o Wrote clinical evaluation reports and updated Design History Files (DHF) to analyze, and document product safety and performance for hemodialysis, peritoneal dialysis systems per CE mark, FDA CFR and ISO guidelines

Courseware Developer 2007 – 2008

Maya Heat Transfer Technologies, Montreal, QC, Canada

o Developed instructor-led and self-training manuals for Thermal & Computational Fluid Dynamic (CFD) solvers integrated in Unigraphics NX5 and NX6 and FEMAP version 9.3 simulation environments

o Created tutorials showcasing solver features for Thermal & CFD analysis of spacecraft systems and electronics board designs

o Created online help documentation for thermal analysis software for printed circuit assemblies

o Documented and addressed customer support calls for training and documentation

CAD Consultant 2006 – 2007

BRT Solutions Inc., Montreal, QC, Canada

o Provided Finite Element Analysis (FEA) services using Pro/Mechanica and solid modeling and detailing support using Pro/Engineer Wildfire 2.0 for Simfinity/IPT simulator product line of Canadian Aerospace Engineers (CAE)

o Developed process to translate geometry between Unigraphics NX2, SolidWorks 2008 and Pro/Engineer

Research Assistant 2004 -2006

Paleolimnology Laboratory, McGill University, Montreal, QC, Canada

o Established procedures and documentation for Geochronology using radioactive isotopes

o Calibrated and maintained a cryogenic gamma spectrometer and software to analyze emission spectrum.

o Created user manuals for operation of electronic gamma spectrometer by biologists

Design and Development Executive 2000 – 2003

Ingersoll-Rand Ltd., Bangalore, KA, India

o Maintained project schedules and coordinated design and manufacturing teams for the Liberty Screed, Blaw-Knox small paver product line for the U.S. market

o Built and structured assemblies using design for manufacture techniques and tolerance analysis, in consultation with manufacturing department team members and external contractors

o Designed, prototyped and tested sheet metal and machined components using Pro/Engineer 2001 and Wildfire 1.0 (3D modeling and 2D detailing) and maintained CAD revisions using Pro/Intralink PDM

o Performed cost analysis and generated bills of materials for the new screed components and subassemblies using an in-house ERP system

o Maintained product data and revised engineering change orders for the assembly of high-pressure screw type air compressors

Contact this candidate