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
Designer
Jessica_Huang
Rapid Prototyping Expert | Low-Volume Manufacturing Specialist
Turnaround: From CAD to physical parts faster than industry standards. ✅ Medical-Grade Compliance: ISO 13485 & ISO 9001&ISO16949 certified processes for automotive, aerospace, and medical devices. ✅ Cost-Effective
Designer
InnovavisionSolutions
Design Engineer
cross-disciplinary projects. ✅ Regulatory-Savvy Designs: Intimate knowledge of FDA 21 CFR 820 & ISO 13485 ensures compliance is baked into your product from Day 1. ✅ Simulation-Driven Approach: Use of computational
Designer
krupalGopal
Design & Development
Development planning Manage and facilitate the design activities related to the QMS documentation of ISO 13485 and 21CFR 820 Actively participation in audits as well as in resolving queries related to design
Job
CAD Designer – Shape the Future of Neurostimulation Technology
body
Bonus Points:
Experience designing products for FDA or CE compliance
Familiarity with ISO 13485 or IEC 60601 standards
Exposure to medical-grade materials and biocompatible design practices
Designer
Bob Barry
Plastic Design, Industrial Design & CAD Design Specialist
resourceful and solving complex problems. • Complete knowledge of Quality System Management for ISO 13485.2008 • Working understanding and knowledge of FDA Regulations for design controls per CFR 820.30
Blog Post
Medical Device Design: A Guide to Service Pricing, Costs, and Rates for Companies
want to acquire international safety certifications issued by ISO. There are at least two types of certifications relevant to medical devices: ISO 14971: a certification of risk management in a medical device