Senior Mechanical Design Engineer

Senior Mechanical Design Engineer

Sunnyvale, CA, United States Not Remote Engineering JOB219463

Job Description

Primary Function of Position

Our Accessories interface between all aspects of the da Vinci system and enable safe and effective robot-assisted surgery. They may be reusable or single-use medical devices (consumables). Our customers interact directly with Accessories in every surgical procedure, and they serve a critical role in customer satisfaction and patient outcomes.

We are looking for a hands-on, technically strong mechanical engineer to design, develop, test, and document new product designs to meet the needs of our customers and our growing business.

The Senior Mechanical Design Engineer for Single-Port Accessories will work on product development of a variety of Accessories. Projects will include a mix of new product development, and product improvements for cost savings and manufacturability to enable significant volume growth. The successful candidate will thrive in a fast-paced environment, have a passion for continuous improvement, and possess the ability to bring cross-functional teams together to solve problems. A strong sense of responsibility and project ownership is required, as well as a commitment to high product quality.

Essential Job Duties

• Work within multi-disciplinary teams to design, develop, and document mechanical components and assemblies for surgical system accessories
• Define functional requirements based on user and product-level requirements and international standards
• Iterate rapidly by prototyping, testing, and analyzing product designs using engineering principles and techniques, including computer simulation and physical models
• Create and maintain product specifications with careful consideration for critical functions and safety while designing for manufacturability and cost
• Support and participate in clinical and human factors evaluations to ensure positive user experience
• Analyze risk of component failure (FMEA) and implement effective mitigations
• Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of designs into production
• Provide mechanical engineering sustaining support for resolution of manufacturing and field issues
• Characterize sources of variations in product performance and implement mitigations accordingly.
• Investigate and determine root cause of design, manufacturing, or material issues.
• Resolve complex engineering challenges through hands-on product testing and collaborate with subject matter experts both internal and external to organization.
• Perform complex tolerance stack analyses to evaluate potential failures or performance concerns
• Maintain Design History Files per regulatory and corporate requirements
• Provide mechanical engineering expertise to support continuous production of high-quality surgical accessories to our customers
• Develop components and product mechanical drawings in a regulated environment for high volume manufacturing processes, including plastic injection molding, thermoset compression molding, machining
• Adept in risk management and design control documentation
• Support design for automation such that our product designs can enable technologies that allow volumes to continue to grow year over year
• Mentor other engineers
• Help establish individual and team goals aligned with overall project and company goals

Qualifications

• Required Skills and Experience

• Prior experience working in a regulated industry (medical device strongly preferred)

• Proficiency with CAD (SolidWorks strongly preferred): designing parts with complex geometry, creating assemblies, creating detailed manufacturing drawings, and analyzing designs with Finite Element Analysis (FEA)

• Demonstrated knowledge of materials (preferably plastics, silicones, isoprenes) and material properties. Ability to apply knowledge of engineering materials and component selection criteria to product designs through strong concept development, design analysis, hands-on prototyping, and reliability testing skills.

• Knowledge of component manufacturing processes (including injection molding, thermoset molding, machining, vacuum thermoforming, pad printing, laser marking, etc.)

• Fluency in GD&T and tolerance stack analysis

• Ability to communicate effectively (written and verbal) across functions, including presenting to a technical audience

• Demonstrated ability to think at a systems level, interface between multiple design groups, and negotiate conflicting requirements

• Demonstrated excitement and capacity to learn and quickly analyze tough technical problems using fundamental principles, strong mechanical intuition, and persistence to pinpoint root cause of problems

• Understanding concepts of design input, design output, requirement traceability, and FMEA risk analysis

• Proficiency at failure analysis, including root cause analysis techniques (e.g., fishbone, 5 Whys, etc.)

• Comfortable operating machine shop, measurement, and test equipment

• Ability to travel up to 10%

• Minimum 8 years of hardware product design experience with undergraduate degree; minimum 6 years with graduate degree.

• Required Education and Training

• Minimum BS in Mechanical Engineering required, MSME preferred. Biomedical or other engineering discipline may be acceptable with appropriate mechanical experience.

• Working Conditions

• Ability to lift 30 lb

• Preferred Skills and Experience

• Proven experience with design for assembly, manufacturing, and automation. Experience working on products with volumes in the 10’s of millions is preferred

• Knowledge in additional manufacturing processes such as extrusion, blow molding, ultrasonic welding, RF welding, heat staking, and laser welding

• Knowledge of sterilization methods, biocompatibility, and packaging of medical devices

• Experience with full product development lifecycle including ideation, design, analysis, debug, verification, qualification, transfer to manufacturing, and sustaining

• Experience leading departmental and cross-functional projects and strategic initiatives from concept through completion

• Sense of shared responsibility and reward

• Ability to utilize deep technical knowledge and broad expertise to achieve company objectives in creative and effective ways

• Additional Information

• Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

• Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

• Mandatory Notices

• U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

• Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).

• For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date