San Francisco Bay Area, CA
Senior R&D Engineer – Disposable Accessories
SAN CARLOS, CA
Disposable Accessories Engineers will participate and influence product design during the development of novel robotically manipulated medical instruments systems. These products will include articulating endoscopes and associated accessories. The engineer will champion their designs through all stages of product development, including; Definition, Ideation, Development, Testing, Risk Management, Verification & Validation, Design Control, DFMA, 510k submission, and support into production release.
- Participate and influence in designing intricate mechanisms, mechanical assemblies and components used in disposable medical devices and supporting instruments & capital equipment.
- Participate in the development of specifications, test methods and protocols to ensure the functionality, safety and efficacy of medical devices in accordance with medical device regulations.
- Lead assessments and makes recommendations for solving challenging design problems at the component level and system level via inspection, testing, analysis, and experimentation.
- Creates and maintains SolidWorks CAD models and detailed drawings.
- Contributes in the transfer of design, specifications and assembly methods for production release.
- Participate in the generation and execution of protocols for verification and validation testing, along with reports.
- Leads technical design reviews presenting design inputs, design outputs and open issues for each product development stage.
- Generates novel ideas that strengthens the company’s IP position in the fields of surgical robotics and minimally invasive surgery.
- Uses Design For Manufacturing and Assembly (DFMA) principles to reduce the cost and simplify assembly.
- Works collaboratively and effectively in a small start-up environment, contributing in many areas with minimal supervision.Requirements:
- ME or Sr ME will be based on previous, successful experience in the medical device arena and demonstration of representative capabilities
- Experience with development of medical devices including: disposable accessories, articulating catheters, endoscopes, and/or surgical instruments.
- Experience in successfully developing single use medical devices.
- Proven experience in SolidWorks CAD system.
- Previous experience with designing for manufacturing processes including: machining, sheet metal, injection molding, polymer extrusions, EDM, laser cutting, rapid prototyping, and cable assemblies.
- Demonstrated ability & successful experience working with cross functional teams.
- S. degree required in Mechanical, Biomedical, or related Engineering discipline.