R&D Engineer
Core
Design, develop, and manage the lifecycle of Infusion Care medical devices, ensuring compliance with regulatory standards and design control processes.
Role type
Senior IC mechanical/design engineer (medical devices)
Builds
New infusion care products, components, and materials
Domain
Medical devices / Infusion Care
Deliverable
product features
Required skills
Mechanical/Design Engineering, CAD (SolidWorks), Design Control, Root Cause Analysis (RCA), Design for Manufacturing/Assembly, Regulatory Compliance (ISO 13485, FDA 21CFR820)
Preferred skills
Systems Engineering, Risk Management (ISO 14971), Intellectual Property generation
Technologies
SolidWorks, CAD software
Responsibilities
Design and develop new products and components; Perform changes on existing products following SOPs; Author and review Design Control and Risk Management documents; Develop and qualify new test methods; Conduct root cause investigations and implement corrective actions; Generate concepts and create 2D/3D models and engineering drawings; Collaborate with cross-functional teams and stakeholders.
Seniority
Senior, hands-on IC