TAAHA JAMKHANAWALA
BioMedical Engineer
Mumbai,Maharashtra
Summary
Results-driven professional with a go-getter mindset and a strong foundation in technical innovation, cross-functional collaboration and effective leadership. Experienced in the areas of medical device development, quality and regulatory affairs. Seeking full-time leadership opportunities in the Medical Device, Healthcare or Pharmaceutical sector, where I can contribute to advancing cutting-edge solutions, optimizing patient outcomes and driving growth through technical excellence and efficient management.
Overview
10
10
years of professional experience
8
8
years of post-secondary education
9
9
Certificates
Work History
EIMEA Client Manager - Regulatory Services Medical
British Standards Institution (BSI)
Mumbai, Maharashtra
06.2021 - 03.2025
- Performed QMS audits as a qualified team member (40%) and team leader (60%) in the areas of ISO 13485, ISO 9001, EU MDD, EU MDR, UKCA and MDSAP, covering technical areas and product codes including passive medical devices, active medical devices, in vitro diagnostic devices, sterile medical devices and software based medical devices.
- Performed and executed testing of complex applications which were used as tools for audit management activities. These applications helped both internal teams and customers in reducing efforts and making process efficient by at least 15%.
- Supported BSI team members, service delivery manager, planning team, clients and compliance and risk team involving pre and post audit activities. I managed to save at least 20% time and rework related effort through effective collaboration and troubleshooting during service delivery.
Mechanical Engineer
Saneso Inc.
Elkins, West Virginia
10.2018 - 01.2021
- Responsible and accountable for assembling and repairing Gastrointestinal Endoscope Systems and Ancillary Equipment following established SOPs and safety procedures, in a timely and qualitative manner, including tasks such as design updates/improvements, process updates/improvements, electro-mechanical assembly/disassembly and troubleshooting system problems. Product development stages covered in above mentioned activities were initial design review and design transfer phase, builds of Rev1 system and builds of Rev2 system in line with ISO 13485, ISO 14971 and product related requirements. The improvement in process gave saving of at least 50% in production output.
- Prepared and maintained necessary regulatory and department documentation for timely regulatory submission related to US FDA 510(k) and EU MDR.
- Conducted hardware and software verification and validation testing in compliance with ISO standards and FDA regulations such as ISO 13485, IEC 60601-1, IEC 60601-1-2, ISO 10993 series, IEC 62366, IEC 62304, ISO 14971 and 21 CFR Part 820 requirements. Successfully handled QMS Stage 1, Stage 2, surveillance audits covering ISO 13485 requirements, and CSA assessment covering IEC 60601 requirements.
- Responsible for organizing and maintaining assembly workstations and inventory management.
Product Development Intern
Nubenco Enterprises, Inc.
Paramus, New Jersey
01.2017 - 09.2018
- Product development and product quality management (RA/QA) of surgical supplies and medical disposable products.
- Performed product portfolio management including improvement of existing and development of new product bill of materials (BoM), technical dossiers, packaging artwork, test methods and STED in compliance with ISO 13485, FDA 21 CFR Part 820 and Medical Device Directive 93/42/EEC.
- Organized and maintained a product laboratory for design, dimensioning, verification, validation and testing of product samples.
- Conducted competitive studies, market research, RCA/CAPA studies, version control, system integration, line differentiation and business model development for our products.
Assistant Research Director - Noninvasive Hypertension Monitor
Cardiovascular Engineering, Modeling and Devices (CVMD) Lab, Rutgers University
New Brunswick, New Jersey
01.2015 - 01.2017
- Responsible for research and design of portable noninvasive vascular stiffness monitoring technology.
- Project lead for electro-optical sensors and detectors.
- Designed bioelectronic circuits and conducting signal processing for clinical monitoring.
- Assisted in supervision and completion of senior design projects.
Researcher - Clinical Immersion Program
Robert Wood Johnson University Hospital
New Brunswick, New Jersey
01.2015 - 02.2015
- Shadowed physicians in colonoscopy, venography, stent placement with angioplasty, interventional radiology, fluoroscopy machine servicing and abdominal resection procedures
- Conducted thorough literature reviews to identify gaps in knowledge and inform future research directions.
- Gathered and organized information for research purposes.
Product Manager
Collateral Medical Pvt. Ltd.
Mumbai, Maharashtra
07.2013 - 07.2014
- Responsible for research, development and manufacturing of Vein light, Bilipatch, Suction Pumps, Blood Pressure Cuffs, Otoscope, X-Ray Viewer, Head Circumference Measuring Tape and Infusor Bags. Product development activities included design, prototyping, testing and outsourced manufacturing.
- Responsible for procurement, marketing and sales of products from suppliers such as 3M, Boston Scientific, OneTouch, GE, Romson, Bard, Nipro, Choicemmed and BPL.
- Performed online customer service and on-field servicing of products such as Stethoscope, Pulse Oximeter, Audiometer, Pharmacy Refrigerator, Fetal Doppler Machine and EEG Machine.
Education
Master of Science - Biomedical Engineering
Rutgers University, School of Engineering
New Brunswick, New Jersey 09.2014 - 05.2016
Bachelor of Science - Biomedical Engineering
University of Mumbai, DJ Sanghvi College of Engineering
Mumbai, Maharashtra 07.2009 - 05.2013
Skills
QMS, US FDA, ISO, EU MDD, UK MDR and 510(k) Regulatory Experience, GMP, cGMP and GCP Experience, Electrical Circuit Design and Testing, Software Testing as per IEC 62304, Data Acquisition and Analysis, Market Research and Analysis, PMS, RCA, CAPA, ERP, CRM, GD&T, EDMS, FMEA, SOP Writing, Material Testing, Administration, Management, CNC, Injection Molding, Prototyping, Patent Writing, Technical Writing, Risk Mitigation as per ISO 14971, Clinical Evaluation, Technical Documentation, Pitching, Inspection & Investigation, Design & Dimensioning, Verification & Validation as per Product Specific Standards, Quality Control, Quality Assurance, Sales, Servicing, Packaging, Sample Testing, Product Lifecycle Management, Graphic Design, HR Recruitment Postings and Management, Medical Device Development, Product Quality, Regulatory Affairs, Engineering
undefinedTimeline
EIMEA Client Manager - Regulatory Services Medical
British Standards Institution (BSI)
06.2021 - 03.2025
Mechanical Engineer
Saneso Inc.
10.2018 - 01.2021
Product Development Intern
Nubenco Enterprises, Inc.
01.2017 - 09.2018
Assistant Research Director - Noninvasive Hypertension Monitor
Cardiovascular Engineering, Modeling and Devices (CVMD) Lab, Rutgers University
01.2015 - 01.2017
Researcher - Clinical Immersion Program
Robert Wood Johnson University Hospital
01.2015 - 02.2015
Master of Science - Biomedical Engineering
Rutgers University, School of Engineering
09.2014 - 05.2016
Product Manager
Collateral Medical Pvt. Ltd.
07.2013 - 07.2014
Bachelor of Science - Biomedical Engineering
University of Mumbai, DJ Sanghvi College of Engineering
07.2009 - 05.2013
Certification
BSI CQI and IRCA Certified ISO 9001:2015 Lead Auditor Training Course
Accomplishments
Publications
- “Robotic Drill for ACL Reconstruction” Bachelor of Engineering thesis.
- “Noninvasive Photoplethysmographic Monitoring of Pulse Wave Velocity and Vascular Stiffness for Hypertension Applications” Master of Science thesis
Leadership
- Qualified Team Leader for ISO 13485, ISO 9001, EU MDD, EU MDR, UKCA and MDSAP audits.
- Senator for Student Affairs, Graduate Student Association (GSA) at Rutgers University, 2015-2016.
- Floor Advocacy Liaison, Residence Hall Association (RHA), Livingston, Rutgers University, 2015-2016
- Event Head of Tech Expo, Beat X212-National Level Inter-Collegiate Festival, DJ Sanghvi College of Engineering, Mumbai, 2011-2012
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
RELEVANT COURSEWORK
- Biomedical Instrumentation
- Applied Clinical Electrophysiology
- Biosignal Processing and Biomedical Imaging
- Innovation and Entrepreneurship for Science and Technology
- Medical Device Development
- Biomechanics & Biomaterials
- Biocontrol, Modeling and Computation
- Clinical Practicum
- Engineering Ethics and Technical Writing
- Numerical Models & Biomedical Systems
- Math Modeling
- Adult and Stem Cell Dynamics
- Robotics
- Electrical Circuits Analysis and Design
- Human Anatomy and Physiology
- BioMEMS
- Biostatistics
- Electrical Network Analysis and Synthesis
- Logic Circuits
- Microprocessors and Microcontrollers
- Biomechanics, Prosthesis and Orthosis
- Nuclear Medicine
- Hospital Management
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