Antik Chakraborty
Temecula
Overview
1
1
year of professional experience
Work History
Supplier Quality Engineer
Abbott Vascular
Temecula, CA
08.2025 - Current
- Owned end-to-end Supplier Change Notifications (SCNs), driving timely risk and impact assessments, crossfunctional alignment with R&D, Manufacturing, and Regulatory teams, and ensuring supplier implementation complied with DOPs, quality agreements, and regional regulatory requirements.
- Qualified and validated new materials, components, and supplier process changes, partnering with Engineering to assess IQ/OQ/PQ impact, component verification, and risk mitigation strategies.
- Served as primary liaison for Third-Party Manufacturers (TPMs) and global supplier quality teams, driving timely issue resolution, escalation management, and alignment across operations and supply chain stakeholders.
- Supported audit readiness and regulatory compliance by maintaining complete supplier documentation, SCN histories, FAI records, and evidence aligned with ISO 13485, FDA QSR, and Abbott Quality System requirements.
- Managed the end-to-end lifecycle of controlled documentation, including Quality Agreements, CAD files, and inspection records, ensuring that BAQPs and MHFs accurately reflected current manufacturing states and regulatory requirements.
Product Development Engineer
Becton Dickinson (BD)
Ithaca, New York
08.2024 - 07.2025
- Led the design and development of a next-gen BD Vacutainer system, reducing needle-side leakage by 95% and lowering healthcare worker exposure by 90% through iterative user-focused redesigns.
- Conducted stakeholder interviews, root cause analysis, and workflow mapping across clinical sites to identify failure modes and usability gaps.
- Directed over 10 iterative design cycles in SolidWorks and aligned designs with CTQ features and human factors standards.
- Developed and executed 15+ V&V test cycles, authored validation protocols and reports aligned with FDA and ISO requirements.
- Applied FMEA methodology and CAPA processes to mitigate product risks and resolve deviations during early-stage testing.
- Partnered with engineering, quality, and clinical teams to build DHF documentation and ensure regulatory traceability.
- Supported validation strategy and MSA planning during transition to manufacturing scale-up under cGMP framework.
- Sponsored Project (Cornell University)
Education
Master of Engineering - Biomedical Engineering
Cornell University
Ithaca, New York01.2025
Bachelor of Technology - Bioengineering
VIT Bhopal University
Bhopal, India01.2023
Skills
- FDA QSR (21 CFR Part 820)
- ISO 13485
- ISO 14971
- EU MDR
- CAPA
- FMEA
- Viewpoint
- Leadership
- Lean Six Sigma
- New Product Development
- Prototype Design
- Team Collaboration
- SolidWorks
- MATLAB
- Python
- Minitab
- OriginPro
- COMSOL
- GSAS II
- FullProf
- ImageJ
- Zetasizer
Timeline
Supplier Quality Engineer
Abbott Vascular
08.2025 - Current
Product Development Engineer
Becton Dickinson (BD)
08.2024 - 07.2025
Bachelor of Technology - Bioengineering
VIT Bhopal University
Master of Engineering - Biomedical Engineering
Cornell University