Designer
Atishkumar
Mechanical Design Engineer
Tolerance stack-up Analysis and apply GD&T. Knowledge of Regulatory affairs QMS ISO 13485 and Medical devices Risk management ISO 14971.
Designer
TechWorks
Senior Mechanical Designer — NX/UG, SolidWorks, GD&T, Thermal Simulation, NPD & NPI Specialist
Manufacturing Support: CNC readiness, vendor drawings, process planning, and quality documentation (ISO 13485 / ISO 9001).
Designer
zeyadelmahmoudy
Mechanical Design Engineer (CSWP)
hands-on experience working in regulated environments, ensuring compliance with IEC 60601, ISO 13485, and ISO 80601-2-12 standards. My work includes creating detailed manufacturing drawings (machining
Designer
A_rahman
Mechanical Design Engineer | CAD Expert | Product Development | SolidWorks Specialist
manufacturability. Medical Gas Pipeline Systems: Developed components and documentation compliant with ISO 13485:2016, including design validation files, BOMs, 2D/3D drawings, and process control documentation
Designer
omrit
Senior R&D Mechanical Engineer | Medical Device Expert | DFM & Precision Design
transforming high-level concepts into market-ready products, with a specialized focus on Medical Devices (ISO 13485) Throughout my career at leading med-tech companies, I have successfully: Optimized Architectures:
Designer
himanshuj2
Project Manager professional with CAD/CAM/CAE experience
Skilled in 3D modeling (SolidWorks, CATIA, Creo), GD&T, FEA, DFM/DFA, and regulatory compliance (ISO 13485, FDA, IATF 16949). Adept at integrating innovative solutions to improve product performance, reliability
Designer
Design Universe
2D Drawing, New Invention Development & Packaging Design Expert
PA, PBT etc. Knowledge on Metals and Steel material selection. Documentation under ISO 9001, ISO 14001, ISO 13485, ISO/TS 16949 standards. Documentation for product approval and customer approval, Inspection
3D Model
Product & Industrial Design & Prototyping| Wearable Medical Devices
Model Various render view High resolution jpeg Product design Patent drawings utility Design IP ISO 13485 Medical devices standard consumer products 3D Case Keyshot: rendering animation exploded view material
Service
Product & Industrial Design & Prototyping| Wearable Medical Devices
Model
Various render view
High resolution jpeg
Product design
Patent drawings
utility Design
IP
ISO 13485 Medical devices standard
consumer products
3D Case
Keyshot:
rendering
animation
exploded view
Blog Post
Medical Device Design and Development: A Step-by-Step Guide to FDA Design Controls
you will be familiarized with the elements under 21 CFR 820.30, the 2026 QMSR harmonization with ISO 13485, device classification, and the 510(k)/De Novo/PMA pathways. For owners who wants to develop a medical