About the job
Role Overview
We are seeking a detail-oriented CAD Designer to support the product engineering team with the mechanical and digital design of our neurostimulation system. This role involves translating conceptual sketches and engineering inputs into accurate 2D and 3D CAD models ready for prototyping, manufacturing, and regulatory submission.
Key Responsibilities
Create detailed 3D models and 2D drawings of implantable medical devices, surgical tools, and external controllers
Collaborate with biomedical engineers, electrical engineers, and regulatory specialists to ensure design intent is accurately represented
Prepare CAD files for rapid prototyping, CNC machining, and cleanroom assembly processes
Maintain version control and revision history of all design files per FDA QSR and ISO 13485 requirements
Assist in the creation of technical documentation and visualizations for design reviews and FDA submissions (e.g., 510(k))
Qualifications
3+ years of experience in CAD design, preferably in the medical device industry
Proficiency with SolidWorks, Fusion 360, or PTC Creo
Strong understanding of DFM, biocompatible materials, and implantable device tolerances
Familiarity with FDA Class II design documentation requirements (DHFs, design inputs/outputs, etc.)
Experience working within ISO 13485 / FDA QSR environments is a plus
Portfolio of past device designs or related components required
What We Offer
Opportunity to contribute to the early-st...
read more
Role Overview
We are seeking a detail-oriented CAD Designer to support the product engineering team with the mechanical and digital design of our neurostimulation system. This role involves translating conceptual sketches and engineering inputs into accurate 2D and 3D CAD models ready for prototyping, manufacturing, and regulatory submission.
Key Responsibilities
Create detailed 3D models and 2D drawings of implantable medical devices, surgical tools, and external controllers
Collaborate with biomedical engineers, electrical engineers, and regulatory specialists to ensure design intent is accurately represented
Prepare CAD files for rapid prototyping, CNC machining, and cleanroom assembly processes
Maintain version control and revision history of all design files per FDA QSR and ISO 13485 requirements
Assist in the creation of technical documentation and visualizations for design reviews and FDA submissions (e.g., 510(k))
Qualifications
3+ years of experience in CAD design, preferably in the medical device industry
Proficiency with SolidWorks, Fusion 360, or PTC Creo
Strong understanding of DFM, biocompatible materials, and implantable device tolerances
Familiarity with FDA Class II design documentation requirements (DHFs, design inputs/outputs, etc.)
Experience working within ISO 13485 / FDA QSR environments is a plus
Portfolio of past device designs or related components required
What We Offer
Opportunity to contribute to the early-stage development of a breakthrough medical device
Direct collaboration with a highly experienced team across regulatory, clinical, and product design
Competitive compensation with equity potential
Fast-paced, mission-driven environment with long-term growth opportunity
read less
Role Overview
We are seeking a detail-oriented CAD Designer to support the product engineering team with the mechanical and digital design of our neurostimulation system. This role involves translating conceptual sketches and engineering inputs into accurate 2D and 3D CAD models ready for prototyping, manufacturing, and regulatory submission.
Key Responsibilities
Create detailed 3D models and...
read more
Role Overview
We are seeking a detail-oriented CAD Designer to support the product engineering team with the mechanical and digital design of our neurostimulation system. This role involves translating conceptual sketches and engineering inputs into accurate 2D and 3D CAD models ready for prototyping, manufacturing, and regulatory submission.
Key Responsibilities
Create detailed 3D models and 2D drawings of implantable medical devices, surgical tools, and external controllers
Collaborate with biomedical engineers, electrical engineers, and regulatory specialists to ensure design intent is accurately represented
Prepare CAD files for rapid prototyping, CNC machining, and cleanroom assembly processes
Maintain version control and revision history of all design files per FDA QSR and ISO 13485 requirements
Assist in the creation of technical documentation and visualizations for design reviews and FDA submissions (e.g., 510(k))
Qualifications
3+ years of experience in CAD design, preferably in the medical device industry
Proficiency with SolidWorks, Fusion 360, or PTC Creo
Strong understanding of DFM, biocompatible materials, and implantable device tolerances
Familiarity with FDA Class II design documentation requirements (DHFs, design inputs/outputs, etc.)
Experience working within ISO 13485 / FDA QSR environments is a plus
Portfolio of past device designs or related components required
What We Offer
Opportunity to contribute to the early-stage development of a breakthrough medical device
Direct collaboration with a highly experienced team across regulatory, clinical, and product design
Competitive compensation with equity potential
Fast-paced, mission-driven environment with long-term growth opportunity
read less