Quality Engineer II - Medical Devices, Design Controls

Intuitive Surgical, Inc. in; Sunnyvale (CA); On-site; USD 104,000 - 141,000; Full time

Benefits offered by this job

Health insurance

401(k)

Job summary

Intuitive Surgical, Inc. in Sunnyvale, CA is seeking a Quality Engineer II to support product development and operations from concept to commercialization.

You will contribute to design control, risk management, and process validation while aligning with Intuitive's quality processes and regulatory requirements. The role calls for collaboration with cross-functional teams, data-driven problem solving, and ensuring product quality throughout the lifecycle.

Qualifications

• Minimum BS in engineering or STEM required.
• 2+ years in quality engineering or related field in medical devices.
• Experience with design control and risk management from design through commercialization.
• Experience with ISO 13485, ISO 14971 and FDA QSR compliance.
• Ability to navigate quality systems with minimal oversight.
• Strong communication to cross-functional teams.

Responsibilities

• Support manufacturing and cross-functional teams to resolve technical problems.
• Collaborate with product development teams and track progress against schedules.
• Provide GMP/ISO/FDA compliance support and audits.
• Apply PFMEA, RCA, CAPA and process validation techniques.
• Perform data analysis with statistical methods (ANOVA, DOE).
• Support SAP, Trackwise, and Agile-based workflows and documentation.

Skills

Design control

Risk management

pFMEAs

CAPAs

FDA QSR

Electromechanical devices

Quality systems

Root cause analysis

Statistics

Education

Bachelor's in Engineering or STEM

Advanced degree preferred

Tools

SAP

Trackwise

Agile

Tableau

PowerBI

Job description

Intuitive Surgical, Inc. in Sunnyvale, CA is seeking a Quality Engineer II to support product development and operations from concept to commercialization.

You will contribute to design control, risk management, and process validation while aligning with Intuitive's quality processes and regulatory requirements. The role calls for collaboration with cross-functional teams, data-driven problem solving, and ensuring product quality throughout the lifecycle.