201 B, N Line St, Lansdale, PA 19446 AREEJ HABIB PAGE 1

(352) 283 - 2013 | areej.habiib@gmail.com

LinkedIn: areejhabib

✓ Driven biomedical engineer with 7 years of combined academia and industry experience in healthcare
✓ Supported ISO 13485 and FDA CFR 21 Product Development of class 2 dug-delivering catheters and class 3 orthopedics
✓ Start-up experience in NPI (New Product Introduction) and Development, QA, Usability Testing, Clinical trial support and Risk control
✓ FDA remediation experience of legacy Biomet hip orthopedics with rigorous Design Control Documentation
✓ Authored 20 technical reports and managed over 2000 complaints
✓ Skilled in CAD (SolidWorks), trained on GD&T, drafting standards and tolerance stack analysis
✓ Proven academic research in biomedical data analysis, machine learning and signal processing using tools such as MATLAB
✓ Implementing IEC62366 and FDA Guidance on Human Factor Engineering to assess risks in design changes
✓ Collaborated with clinicians and surgeons to generate conceptual products for unmet clinical needs
✓ Good writing skills: generated industry-level V&V reports and academic papers: Read my Master’s Project

PROFESSIONAL EXPERIENCE

Thrombolex Inc | Peregrine Surgical, New Britain, PA

Product Development Engineer June 2018 – Present
• Support NPI of a combination drug delivery device for catheter-directed thrombolysis
• Rapidly execute design iterations, create CAD engineering drawings (SolidWorks) and conduct Risk Assessment (ISO 14971)
• Design and development of Usability studies based on FDA guidance on HFE (Human Factor Engineering) and IEC 62366 standards
• Technical documentation review for FDA submissions such as 510K, Investigation Devices and human clinical trials
• Quality & Operations support: generating QA protocols, reviewing Standard Operating Procedures (SOP), Work Instructions (WI)
• Conducted competitive market analysis, work closely with clinical sales team to identify business opportunities and market gaps
• Project management: Developed an optimal packaging solution for catheter involved identifying third-party vendors and screening based
on quality and ISO compliance, translating customer needs to product specs, budgeting and managing multi-department communication

Zimmer Biomet, Warsaw, IN

Development Engineer August 2017 – June 2018
• Worked cross-functionally with Quality and Regulatory specialists to identify and close verification gaps for legacy Biomet orthopedics
• For risk identification and assessment of five hip implant product families investigated over 2000 complaints, generated 20 Complaint
Analysis Reference Reports and audited ICFARRs (IE, CAPA, Field Action Reference Reports)
• Executed geometric evaluation of femoral stems, acetabular cups and instruments via tolerance stack-ups and dimensional layouts
• Reviewed Design History Files and Design Control Traceability Matrix
• Facilitated post-market surveillance: routed product changes, identified Non-conformances and reviewed Engineering Change Orders
• Conducted Critical Feature analysis of stem insertion and extraction tools and their functional interaction with compatible products
• Supported CAPA initiation activity for a third-party vendor of a femoral stem, collaborated closely with Supplier Quality Engineer

University of Florida, Whitney Lab of Marine Biosciences, Gainesville FL

Summer Research Fellow June 2017 – August 2017
• Designed behavioral experiments to track fish activity and swimming kinematics to generate predictive algorithms for biotelemetry
• Optimized the data collection system (3-axis accelerometers and High-speed camera - 150 fps) to overcome gaps in data synchronization
• Used MATLAB for data condensation, signal processing, feature extraction (through photo digitization) and data analysis
• Condensed data to extract relevant features recognize a unique behavioral motion based on fish tail frequency with accuracy of > 90%

Delhi University, Plant Molecular Biology, New Delhi, IN

Research Assistant May 2013 – July 2013
• Created promoter constructs of the viral DNA extracted from infected Cassava plant and cloned specific DNA sequences
• Molecular biology techniques: recombinant DNA technology, Polymerase Chain Reaction etc. to study gene expression and quantification

ACADEMIC PROJECTS

3D Simulation of Human Gait

• Simulated human gait using inverse dynamics which involved defining the entire gait system: specific torques, angles and actuated forces
• Conducted sensitivity analysis to test impact of a prosthetic leg on gait. Tools used: MATLAB and Motion Genesis
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Neural Encoding of Spike Trains recorded from Cortical Motor Neurons

• Analysed EEG signals recorded from Macaque monkeys during a motor task in response to direction-based stimuli
• Mapped cortical neuron response activity in MATLAB in raster plots and histograms to characterize them
• High spike activity in PMd neurons as opposed to M1 neurons suggests predisposition to direction/orientation-based stimuli

Bioactive Spine Implant C-Brace

• Presented a solution to a clinician investigating prevention of Pseudoarthrosis in scoliotic patients undergone a spinal fusion surgery
• Provided a comprehensive plan for design, prototype testing, development, verification and validation studies, regulatory pathway and
commercialization plan for the product

Likelihood of a Reddit comment being Upvoted

• Used data-driven approach to predict how many up-votes/down-votes a comment on Reddit is likely to get
• Used semantic analysis, topic modelling and nature language processing (genism and NLTK libraries in Python) for feature extraction and
techniques such as bagging and boosting to optimize the algorithms
• Implemented traditional machine learning algorithms Decision Trees, SVM, k-NN demonstrated accuracy between 70-79% for multiclass
classification of a biased dataset.

EDUCATION

University of Florida, Gainesville

Master of Science in Biomedical Engineering August 2015 – May 2017
GPA: 3.46/4
Coursework: Neural Engineering, Statistical Methods, Engineering Innovation, Cell/Tissue Engineering, Analytical Dynamics, Pattern
Recognition, Machine Learning in Health, Clinical Preceptorship

National Institute of Technology, Warangal, India

Bachelor of Technology, Biotechnology August 2010 – May 2014
GPA: 7.8/10
Coursework: Genetic Engineering (with Lab), Drug and Pharmaceutical Biotechnology, Microbiology, Bio-nanotechnology,
Immunotechnology, Mathematics -I/II/III/IV, Fluid Mechanics & Heat Transfer, Problem Solving and Computer Programming, Engineering
Mechanics, Engineering Graphics