R & D Engineer

Essential Job Functions

• Design & Prototyping: Build preliminary sketches, 3D models, detailed design concepts, and engineering prototypes. [1]
• Testing & Validation: Plan and run benchtop tests, verification and validation (V&V), and pre-clinical studies, writing clear protocols and reports. [1]
• Tooling: Make tools, jigs, and fixtures to help with testing, prototyping, and manufacturing. [1]
• Documentation: Write product drawings, risk analysis, specifications, and keep the Design History File (DHF) updated for regulatory compliance. [1]
• Collaboration: Help with product transfer, scale-up activities, and share new ideas to grow the company's patent and intellectual property base. [1]
• Lab Support: Keep the R&D lab clean and organized for smooth prototype development. [1]

Job Requirements

• Education: Bachelor's degree or higher in Biomedical, Mechanical, or Materials Engineering. [1]
• Experience: Minimum of 2 years of engineering experience in product development or manufacturing within a regulated medical device industry. [1]
• Technical Skills: Strong working knowledge of SolidWorks for 3D modeling and engineering drawings. [1]
• Core Skills: Good problem-solving abilities, strong technical writing skills, and familiarity with FDA submissions, ISO standards, and Quality System Regulations (QSR)