Senior NPD Engineer

Intuitive Surgical • Sunnyvale, CA

45d

About The Position

Primary Function of Position: Intuitive Surgical, Inc. produces the Ion Bronchoscopy system, a minimally invasive robotic catheter system that accesses deep into the lungs and offers treatment not possible with conventional tools. This senior engineer role will focus on design controls, complaints investigations, supporting global expansion efforts, and supporting operations for flexible instruments and accessories that interface with a robotic system, including a steerable catheter. The engineer will support both early-stage development, where creativity and agility are essential, and later-stage development, where attention to detail and quality are critical. Responsibilities include developing design requirements and associated test methods to ensure performance, safety, and reliability, as well as owning or supporting key design control deliverables such as design inputs/outputs, risk management, and verification/validation of designs. The ideal candidate will possess the technical expertise to understand complex mechanical designs and a passion for integrating quality into products. A strong sense of shared responsibility and commitment to high product quality is essential.

Requirements

• BS in Engineering, Materials Science or related scientific discipline required.
• Minimum 6 years of experience developing commercial medical products. Advanced degrees may substitute for experience.
• Experience designing/managing catheter-based devices with electrical integration preferable.
• Experience owning all design control deliverables on catheter-based products.
• Experience in all phases of the product development lifecycle including requirements definition implementation, debug, risk management, verification/validation, and transfer to manufacturing.
• Demonstration of strong analytical ability to test and assess design concepts, evaluate complex interface and associated performance risks throughout design and development cycle
• Proficient in CAD to develop test fixturing and to review designs; SolidWorks preferred.
• Hands-on engineering with ability to work well in a team environment.
• Excellent written and communication skills.
• Experience with managing large volumes of data and data analysis.
• Ability to travel up to 5% time.

Responsibilities

• Define and test design input requirements for sterile and reprocessable instruments and accessories based on user needs, product risks, and global standards.
• Partner with design and clinical engineers to evaluate and down-select design architecture for early-stage product design.
• Use first principles to identify critical product performance features, design test equipment, test and analyze product, and define acceptance criteria.
• Implement testing strategies to challenge designs to ultimately identify and implement critical design controls.
• Partner with SMEs to define product/test requirements and evaluate designs relative to electrical safety, biocompatibility, sterilization/cleanliness, and labeling/packaging/transit.
• Collaborate on the development of risk management and design control documentation for product development programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Number of Employees: 1-10 employees