BioMedical Engineering

PARAM SHAH

484-***-**** **********@*****.*** Linkedin: ParamShah

EDUCATION

Drexel University, Philadelphia, Pennsylvania

Master of Science (M.S.), Biomedical Engineering, GPA: 3.55/4 Sept 2016 – June 2018 Gujarat Technological University, L.D. College of Engineering, Ahmedabad, India Bachelor of Engineering (B.E.), Biomedical Engineering, CGPA: 8.02/10 July 2012 – May 2016 WORK EXPERIENCE

Research Assistant, Orthopedic Biomechanics Lab, Drexel University, Philadelphia, Pennsylvania Modelling Region Specific Growth of the Pediatric Thoraco-Lumbar spine with and without Instrumentation using Finite Element Method (National Science Foundation Award Abstract #1748167 EAGER).

• Developed FE model of pediatric lumbar spine and pelvis using block meshing in ICEM CFD using vertebral geometry.

• Simulated growth of the FE model using Ansys and Hypermesh and validate growth using pediatric growth data published by Orthopedic Biomechanics Lab.

• Analyzed effect of growth on instrumentation and how it will help to correct deformity over time by different stress analysis and placement of instrumentation in collaboration with Globus Medical.

• Designed a posterior lumbar interbody fusion instrumentation using Pro/E, assembled various parts of model using Solidworks. Designed/edited various Inter-spinal cervical/Thoracic implants and Intervertebral Disc spacers design history files.

• Developed a system level validation and verification test procedure for running FE template. Worked on developing a FMEA, DOE, SOPs and testing reports for this project. Worked closely with company employee to run mechanical testing on fixtures and implants to comply with 21CFR820 and class III regulatory rules for FDA.

• Presented my work at NEBEC 2018 and 8th World Congress of Biomechanics 2018 (Dublin, Ireland).

• Lead the bi weekly project meeting updates with Globus Medical and worked as bridge between Orthopedic Biomechanics Lab and Globus Medical.

Quantification of Osteonal Parameters of Skeletally Immature Porcine Femur Sept 2016 – Dec 2016

• Utilized Osteons distributions to understand the overall internal structure of trabecular bone in femur.

• Analyzed microscopic images with stereo investigator and Adobe Photoshop to examine microstructure in images processed using custom MATLAB code.

Summer Engineering Intern, NH Hospital, Ahmedabad, India May 2015 – July 2015

• Analyzed the SOPs of various medical devices and their process of operation for the patient treatment.

• Studied about cGMP compliance and regulations for manufacturing of the medical instruments.

• Learned about maintenance and various validation protocols using IEEE standards and black box testing.

• Performed CAPA for the defects in devices, studied SOPS and prepare statistical data reports using FMEA. ACADEMIC PROJECTS

Ultrasound Wound Healing Device – Biomedical Entrepreneurship Project Jan 2017 – April 2017

• Identified the 21 CFR 820 and ISO 13485 requirements for a fictious medical device company and mapped traceability matrix; created I/O diagram for each subsystem after defining inputs and outputs of the subsystem.

• Designing the flowchart, architecture and drafted the subsystems overview for Quality Manual and applied Design Controls.

• Preparing SOPs, Work Instructions and forms for documentation in Design History File (DHF) and Device Master Record

(DMR); applying theoretical understanding of FMEA and DOE design to practice with hypothetical industrial and commercial risk-based issues for analysis.

Crack Propagation study using Finite element analysis Sept 2017 – Dec 2017

• Investigated crack initiation and propagation in C-T Specimen using sub-modelling method to study classic fracture mechanics in finite element methods.

• Evaluated various stress and strain analysis at the peak of the fracture using sub structuring method.

• Preparing SOPs, Work Instructions and forms for documentation in Design History File (DHF) and applying theoretical understanding of DOE design to practice with hypothetical industrial and commercial risk-based issues for analysis. Ultrasound Nerve Modulation Device – Medical Device Instrumentation Project/Quality-Regulatory Jan 2017 – April 2017

• Developed a hypothetical Nerve modulation system to market in US and Europe, implementing De Novo Pathway (FDA) and Clinical Data Review (CDR) approach (MFDS) for approval.

• Considered preclinical/clinical trial considerations and reviewed national and international standards for Quality compliance.

• Drafted anticipated risk plan and proposed mitigating activities using ISO 14971 for guidance. TECHNICAL SKILLS

• Comprehensive knowledge of ISO 13485, ISO 14971, ISO 9000, ISO 9001 regulations, Medical Devices Directive (MDD), PMA, IDE and 510 (k).

• Familiar with 21 CFR 210, 21 CFR 211, FDA Quality System Regulation (QSR) (21 CFR 820), National and International Standards (FDA), and Clinical Trials.

• Practical understanding of CAD, GD&T, rapid prototyping, Finite Element Analysis and design validation.

• Practical understanding about the FMEA, DOE, Lean Manufacturing and Six Sigma Principles.

• Software Skills: Proficient in ANSYS, Abaqus, Mimics, Hypermesh, Pro/E, Solidworks,AutoCAD, Ls Dyna, ICEM CFD, Microsoft Word, Excel, Access, PowerPoint, Outlook, Adobe Acrobat, SPSS and MATLAB,Minitab. RELATED LINKS

Academic Projects

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