Senior Mechanical Design Engineer - New Product Development

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.

The Instrument and Accessories team at Intuitive is a cross-functional team dedicated to the creation of innovative medical robotic tools and technologies. We create transformational technologies to address the major pain points and unmet needs in our healthcare system.

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient outcomes as our highest priority. The Senior Mechanical Engineer will focus on the development of robotic surgical instruments for minimally invasive surgical applications.

The successful candidate will have both the technical depth to resolve complex mechanical, materials and manufacturing design issues and the ability to work in an interdisciplinary team to troubleshoot to root cause higher level system issues. They must excel in a high-energy, focused, small-team environment, and have a commitment to high quality prototypes and concepts and a demonstrated record of developing and creating innovative engineering solutions.

A strong sense of shared responsibility and reward is required as well as a commitment to high product quality.

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 - Provide written protocols, reports, presentations, and perform technical design reviews to solicit feedback on design activities on an ongoing basis - Development and documentation of mechanical design and manufacturing documentation including: inspection procedures, assembly instructions, new manufacturing processes, test methods, purchase specifications, BOMs, component / assembly drawings per the company's operating procedures - 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

- Minimum 8 years of experience developing commercial medical products - Demonstrated ability to work in cross-functional research and development teams - Command of evaluating designs via prototype testing and rigorous mathematical analysis - 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

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

- Must be able to lift, carry and move 50 lbs. - Routinely lifts, carries and moves 10 lbs.

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

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

Required Skills and Experience

• Minimum 8 years of experience developing commercial medical products
• Demonstrated ability to work in cross-functional research and development teams
• Command of evaluating designs via prototype testing and rigorous mathematical analysis
• 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

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

• Must be able to lift, carry and move 50 lbs.
• Routinely lifts, carries and moves 10 lbs.

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

The Instrument and Accessories team at Intuitive is a cross-functional team dedicated to the creation of innovative medical robotic tools and technologies. We create transformational technologies to address the major pain points and unmet needs in our healthcare system.

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient outcomes as our highest priority. The Senior Mechanical Engineer will focus on the development of robotic surgical instruments for minimally invasive surgical applications.

The successful candidate will have both the technical depth to resolve complex mechanical, materials and manufacturing design issues and the ability to work in an interdisciplinary team to troubleshoot to root cause higher level system issues. They must excel in a high-energy, focused, small-team environment, and have a commitment to high quality prototypes and concepts and a demonstrated record of developing and creating innovative engineering solutions.

A strong sense of shared responsibility and reward is required as well as a commitment to high product quality.

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
• Provide written protocols, reports, presentations, and perform technical design reviews to solicit feedback on design activities on an ongoing basis
• Development and documentation of mechanical design and manufacturing documentation including: inspection procedures, assembly instructions, new manufacturing processes, test methods, purchase specifications, BOMs, component / assembly drawings per the company’s operating procedures
• 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