Ejaz Ahamed
| Medical Devices | IVD | Combination Devices Experienced in Design & Development, systems engineering, Quality & Regulatory of Medical Devices Industry.
- Role
- Sr Product Quality Assurance at Vantive
- Location
- Raichur, KA, IN
- LinkedIn followers
- 500 followers
About Ejaz Ahamed
Engineer working in Product Development Regulatory Affairs, design quality Assurance and Sustainability of Medical device.Product Design Experience:*Work Experience in Plastic Product Design, Sheet metal and surface Design, Concept Design via Reverse Engineering/Teardown, EU-MDR, DHF Remediation and Design Control as per 21CFR820.30 and ISO 13485.*Good skilled in CATIA V5 (solid modeling, Surfacing and Sheet metal), NX CAD design tools, Teamcenter and good understanding of GD & T & DFX(DFA, DFM, DFQ).Regulatory Affairs and Quality Assurance Experience:* Sound knowledge of ISO 13485:2016, EN/ISO 14971:2012/2007, IEC 60601-1, IEC 60•••16/IEC 62366, ISO 10993, ISO 15223-1, EN 1041, REACH.* Design Controls : Experience in User needs and Design Inputs creation, DCTM, RTM Creation, Technical File/DHF creation, verification and validation of medical devices.* Risk Management: Work experience in creating Risk Management plan, Preliminary Hazard Analysis, DFMEA, PFMEA, Risk Management Report for Active medical devices, Hip Implants and External Fixation systems.* Sound knowledge of IEC, UL & ISO standards and their application with the product design.* Basic understanding in updating risk management files based on post market surveillance feedback like complaints, clinical data.* Active communication with the client for having intimation, to check and approve the design documents.
Experience
Sr Product Quality Assurance
Sep 2025 — Present · Bengaluru, IN
Education
Nitte Meenakshi Institute of Technology
Bachelor of Engineering - BE, Mechanical Engineering
2010 — 2014
The National Institute Of Engineering, Mysore
M.Tech , Machine Design
2015 — 2017
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