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 companys patent and intellectual property base. 1
• Lab Support: Keep the R&D lab clean and organized for smooth prototype development. 1

Job Requirements

• Education: Bachelors 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)

Required Experience:

IC