Staff Mechanical Design Engineer

Primary Function of Position

Intuitive Accessories are the interface between all aspects of the da Vinci system and enable safe and effective robot-assisted surgery. The Staff Mechanical Design Engineer for Single-Port (SP) Accessories will support development and production of existing and new products. This position requires a hands-on, technically strong engineer to dive deep into solving engineering challenges, and to provide high-level assessment of risks and opportunities. Projects will include a mix of sustaining existing products and new product development, including improvements for cost savings and manufacturability to enable significant volume growth, enhancements to increase customer satisfaction, and improving reliability.

Essential Job Duties

• Drive Design efforts to optimize performance, manufacturability and reliability of existing and future Da Vinci SP Accessories.
• Develop components and product mechanical drawings in a regulated environment for high volume manufacturing processes, including plastic injection molding, thermoset compression molding, extrusion, and machining.
• Design for manufacturing and automation, sterilization processes, and biocompatibility.
• Work cross-functionally with Manufacturing Engineers, Systems Analysts, Clinical Development Engineers, Human Factors Engineers, and Supplier Engineers.
• Review and understand product functional requirements and design specifications.
• Provide mechanical engineering sustaining support for resolution of manufacturing and field issues.
• Investigate and determine root cause of design, manufacturing, or material issues.
• Research, understand, and design to relevant product-specific international standards.
• Develop, implement, test, and document solutions that meet clinical, functional, and product requirements.
• Perform and document risk analyses (FMEA) and implement effective mitigations, following design control processes.
• Help identify and develop vendors to manufacture components.
• Develop initial fixtures and processes to assemble components.
• Develop product and component verification testing and product validation testing.
• Support production of final product by troubleshooting process and component problems.
• Provide engineering support to Manufacturing, Materials, Test Engineering, and Service to facilitate transfer of designs.
• Develop, implement, test and document solutions for these opportunities according to corporate standard and departmental operating procedures.
• Mentor other engineers and champion best practices for mechanical design.

Required Skills and Experience

• Proficiency using CAD to design and document mechanisms; SolidWorks strongly preferred.
• Good communication and documentation skills.
• Experience in designing high volume consumable medical products.
• Strong working knowledge of GD&T.
• Experience with complex interface compatibility and tolerance analysis.
• Demonstrated knowledge of high-volume component manufacturing processes (including injection molding, plastics films, extrusions, thermoforming, and plastic bonding methods).
• Demonstrated knowledge of materials (preferably plastics, silicones, polyurethanes, isoprenes) and material properties.
• Demonstrated ability to think at a systems level, interface between multiple design groups, and negotiate conflicting requirements.
• Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer.
• A passion for solving tough technical problems - Strong mechanical intuition and persistence to drill down to pinpoint root cause of problems, solving problems using fundamental principles.
• Ability to communicate effectively (written, oral) across functions, including presenting to a technical audience.
• Prior experience working in medical device or other regulated industry.

Required Education and Training

• Minimum education: BS in Mechanical Engineering required, MSME preferred. Biomedical or other engineering discipline may be acceptable with appropriate mechanical experience.
• Minimum 12 years of hardware product design experience preferred with undergraduate degree; minimum 8 years with graduate degree.

Working Conditions

Ability to lift 30 lbs. without assistance.

Preferred Skills and Experience

• Comfortable operating machine shop tools/equipment, Rapid prototype equipment (3-d printers, laser cutters etc.), measurement and test equipment.
• Knowledge in additional manufacturing processes such as extrusion, blow molding, ultrasonic welding, RF welding, heat staking, and laser welding.
• Comfortable with concepts of design input, design output, traceability, and risk analysis.
• Ability to handle ambiguity effectively and oversee multiple projects at once.
• Knowledge of ISO requirements and GMP guidelines. Experience with FDA regulations and medical device design control a strong plus.
• Experience leading departmental or cross-functional projects/initiatives from concept through completion.
• Knowledge of sterilization methods, biocompatibility, and packaging of medical devices.