Senior Medical Device NPD Engineer

Socket.dev; Sunnyvale (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Intuitive Surgical seeks an experienced engineer to drive end-to-end medical device development. You will collaborate across mechanical, electrical, software, and clinical teams, translating needs into designs and leading prototypes through transfer to manufacturing.

Travel up to 20% is required. Biomedical regulations and design controls are part of daily work as you help ensure safe, reliable, manufacturable products in a regulated environment.

Qualifications

• 3+ years of experience in new product development, product design, manufacturing engineering, or a related engineering role.

Responsibilities

• Collaborate with multidisciplinary technical teams, Product Development, and Clinical Development to translate clinical, customer, and user needs into engineering requirements, specifications, and product designs.
• Lead and support new product development activities across mechanical, electrical, and electromechanical systems from concept through design transfer and commercialization.
• Rapidly develop, prototype, test, and iterate full-scale mechanical and electromechanical prototypes to meet product requirements and performance objectives.
• Design cables, mechanical components, assemblies, and electromechanical interfaces, and generate detailed engineering drawings, specifications, and documentation suitable for volume manufacturing.
• Apply Design for Manufacturing (DFM), Design for Assembly (DFA), and Design for Reliability (DFR) principles to develop scalable and cost-effective product designs.
• Develop and maintain product documentation including mechanical drawings, BOMs, specifications, assembly documentation, and engineering change documentation within a regulated environment.
• Drive system integration builds, debugging, verification, and testing, identifying and resolving mechanical, electrical, and system-level issues.
• Develop a strong understanding of overall system architecture, functional interactions, and interdependencies between mechanical, electrical, software, and other subsystems.
• Lead and facilitate technical trade-off analyses for component selection, including COTS components, manufacturability, reliability, availability, and risk.
• Partner with Manufacturing Engineering and Automation teams to develop fixtures, tooling, assembly processes, and manufacturing methods for new products.
• Support the development and optimization of assembly processes and manufacturing equipment to enable efficient and repeatable volume production.
• Work closely with suppliers, Sourcing, and Buyers to evaluate component and manufacturing capabilities, resolve technical issues, and ensure designs are aligned with supplier processes and capabilities.
• Support design transfer and product transfer to manufacturing, ensuring engineering requirements, drawings, specifications, processes, and documentation are complete and production-ready.
• Provide hands‑on engineering support during pilot builds, production builds, and product ramp, troubleshooting mechanical, electrical, component, and process‑related issues.
• Identify root causes of production and component problems and implement corrective and preventive actions to improve product quality, manufacturability, and reliability.
• Support verification and validation activities, including test planning, fixture development, test execution, and analysis of results.
• Work within applicable quality and regulatory processes, ensuring product development and manufacturing activities comply with company procedures and relevant regulatory requirements.
• Participate in design reviews, risk assessments, and cross‑functional technical reviews, contributing to FMEA, risk management, and design control activities as required.
• Establish and maintain effective relationships with Engineering, Manufacturing, Quality, Regulatory, Clinical, Sourcing, and external suppliers to drive projects toward key milestones.
• Help establish and achieve individual and team technical goals aligned with overall project objectives and company strategy.

Skills

Product development

Mechanical design

Electromechanical

Prototyping

System integration

DFM/DFA

Troubleshooting

Cross-functional teamwork

Documentation

GD&T

Electrical systems

Education

Bachelor's in Mechanical/Industrial Eng or similar (5+ yrs)

Master's degree +3 yrs

Tools

SolidWorks

Electrical CAD

Job description

Intuitive Surgical seeks an experienced engineer to drive end-to-end medical device development. You will collaborate across mechanical, electrical, software, and clinical teams, translating needs into designs and leading prototypes through transfer to manufacturing.

Travel up to 20% is required. Biomedical regulations and design controls are part of daily work as you help ensure safe, reliable, manufacturable products in a regulated environment.