Mechanical Engineer, Product Engineering

Intuitive•San Francisco, CA

About The Position

The Mechanical Engineer, Product Engineering for Single-Port Accessories provides engineering support across Intuitive’s surgical accessory portfolio. The role focuses on product improvements that support cost savings, manufacturability, and volume growth, as well as enhancements to reliability and usability. The successful candidate works in a fast-paced environment, brings cross-functional teams together to solve problems, and demonstrates ownership and a strong commitment to quality. The engineer designs, develops, and documents mechanical components and assemblies for surgical system accessories, including components made using plastic injection molding, thermoset compression molding, and machining. The role also includes defining functional requirements, maintaining design history files, assessing and mitigating component failure risks, and developing product specifications and engineering drawings. The engineer troubleshoots issues, iterates on solutions through prototyping and testing, supports clinical and human-factors evaluations, and collaborates with manufacturing and supplier engineering to transfer designs into sustainable production. The role requires a minimum BS in Mechanical Engineering, with a master’s degree preferred, and at least four years of hardware product design experience with an undergraduate degree or at least two years with a graduate degree. Travel may be required up to 10%.

Requirements

Minimum BS in Mechanical Engineering; a biomedical or other engineering discipline may be acceptable with appropriate mechanical experience.
Minimum four years of hardware product design experience with an undergraduate degree, or minimum two years with a graduate degree.
Ability to learn quickly and analyze difficult technical problems using fundamental principles, mechanical intuition, and persistence to identify root causes.
Ability to think at a systems level, work across multiple design groups, and negotiate conflicting requirements.
Commitment to continuous improvement and quality.
Understanding of design input, design output, requirement traceability, and FMEA risk analysis.
Knowledge of mechanical analysis, including statics, dynamics, and strength of materials.
Ability to design for reliability and manufacturability.
Exposure to the full product development lifecycle, including ideation, design, analysis, debugging, verification, qualification, manufacturing transfer, and sustaining.
Knowledge of engineering materials and their properties; ability to apply materials knowledge and component selection criteria to product design.
Experience designing plastic components and assemblies.
Knowledge of component manufacturing processes, including injection molding, thermoset molding, machining, vacuum thermoforming, pad printing, and laser marking.
Proficiency with CAD for part and assembly design, detailed manufacturing drawings, and FEA; SolidWorks is strongly preferred.
Proficiency in failure analysis and root-cause techniques such as fishbone analysis and 5 Whys.
Fluency in ASME Y14.5 GD&T and tolerance stack analysis.
Comfort operating machine shop, measurement, and test equipment.
Ability to create and execute engineering test plans and write engineering test reports.
Effective written and verbal communication across functions, including presentations to technical audiences.
Ability to travel up to 10%.

Nice To Haves

Master of Science in Mechanical Engineering.
SolidWorks proficiency.
Knowledge of plastics and silicone rubber and their material properties.
Experience leading cross-functional meetings.
Knowledge of sterilization methods, biocompatibility, and medical-device packaging.
Knowledge of additional manufacturing processes, including extrusion, blow molding, ultrasonic welding, RF welding, heat staking, and laser welding.
Prior experience in a regulated industry, preferably medical devices.
Ability to excel in a fast-paced, high-transaction, mass-production environment.
Ability to apply deep technical knowledge and broad expertise creatively and effectively to achieve company objectives.
A sense of shared responsibility and reward.

Responsibilities

Work within multidisciplinary teams to design, develop, and document mechanical components and assemblies for surgical system accessories, including parts made through plastic injection molding, thermoset compression molding, and machining.
Review and define functional requirements based on user and product-level requirements and international standards, and maintain Design History Files in accordance with regulatory and corporate requirements.
Analyze component failure risk using FMEA and implement effective mitigations.
Create and maintain product specifications, including engineering drawings, with attention to critical functions, safety, manufacturability, and cost, in accordance with corporate operating procedures.
Troubleshoot issues and identify root causes using thorough and logical methods.
Rapidly iterate design solutions by prototyping, testing, and analyzing with engineering principles and techniques, including computer simulation and physical models.
Support and participate in clinical and human-factors evaluations to promote a positive user experience.
Collaborate with manufacturing and supplier engineering to transfer designs into sustainable production.
Establish individual goals aligned with overall project and company goals.
Create and execute engineering test plans and write engineering test reports.
Communicate effectively in writing and verbally across functions, including presentations to technical audiences.