Staff Quality Engineer, Medical Devices & NPD Leader

SmartRecruiters, Inc.; Sunnyvale (CA); On-site; USD 177,000 - 255,000; Full time

Job summary

Intuitive Surgical, a global leader in robotic-assisted surgery, seeks a Staff Quality Engineer 5 for New Product Development. This role leads enterprise quality initiatives, shapes practices, and influences decisions across units. Requires broad autonomy and recognized technical leadership.

The position focuses on design controls, risk management, and ensuring GMP/ISO/FDA compliance while advancing scalable, safe products for patients worldwide.

Qualifications

• Minimum 12 years in Medical Device QE/QA with engineering degree or equivalent experience.
• Deep understanding of quality principles and regulatory standards (GMP, ISO, FDA).
• Strong data analysis, investigation, and stakeholder influencing abilities.

Responsibilities

• Leads enterprise quality initiatives across multiple business units or sites.
• Establishes standards and methodologies adopted beyond local teams.
• Owns critical CAPAs and quality investigations, and mentors engineers.

Skills

Quality principles

Data analysis

Issue resolution

Mentor engineers

Executive presence

Cross-functional collaboration

Education

Bachelor's degree in engineering

Job description

Intuitive Surgical, a global leader in robotic-assisted surgery, seeks a Staff Quality Engineer 5 for New Product Development. This role leads enterprise quality initiatives, shapes practices, and influences decisions across units. Requires broad autonomy and recognized technical leadership.

The position focuses on design controls, risk management, and ensuring GMP/ISO/FDA compliance while advancing scalable, safe products for patients worldwide.