Senior Mechanical Design Engineer - New Product Development

Primary Function of Position

The R&D group within Intuitive Surgical is searching for a senior mechanical engineer with a focus on the mechanical design of surgical instruments, contributing to the exploration of a novel system concept and optimization of established system concepts for a new application of surgical robotics. This role is an exciting opportunity to join a small and innovative team focused on successful implementation of product development.

Essential Job Duties

• Design and develop novel robotic surgical instruments, including design and procurement of components, prototype assembly and builds, and design and development of testing and assembly fixtures and methods.
• Work in a small, cross-functional team to define and develop product requirements and functional specifications for robotic instruments, subsystems, and systems.
• Analyze and test product prototype designs, critically analyze results, and present results to the engineering team.
• Create and maintain SolidWorks CAD databases, including components, assemblies, and detailed drawings.
• Contribute to and make decisions based on risk assessments, industry standards, and regulatory frameworks.
• Observe pre-clinical and clinical cases and interface with clinical experts to inform designs and identify user needs through workflow analysis.
• Document, prepare and review patent submissions.

Qualifications

• Minimum 8 years of experience developing commercial medical products.
• Demonstrated ability to work in cross-functional research and development teams.
• Ability to investigate and determine root cause of both latent and emerging design problems.
• Experience with metals, plastics, fabrication methods, plastics molding, MIM, extrusions, process equipment, adhesives, and/or disposable medical products are a strong plus.
• Proficiency using CAD to design and document mechanisms; SolidWorks preferred.
• Experience with GD&T and other related ASME/ISO drafting standards and tolerance stack analysis.
• Experience with all phases of the product development lifecycle including design, implementation, debug, verification, validation, qualification, and transfer.
• Experience with FDA QSR 21 CFR Part 820, ISO 13485, IEC 60601 and other related external standards.
• Excellent written and communication skills.

Required Education And Training

• Minimum BS or MS in Mechanical Engineering, Mechatronics, Materials Science or related engineering or scientific discipline, or equivalent work experience.

Preferred Skills And Experience

• Experience with robotics.
• Familiarity with electromechanical design, PCBAs, sensors and flexible circuits.
• Experience with design of experiments (DoEs) and statistical review.