Sr. QE Engineer

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

Job summary

Intuitive Surgical in Sunnyvale, CA is seeking a Senior Quality Engineer to guide design controls, risk management, and lifecycle processes from concept to commercialization. You will ensure compliance with ISO 13485, ISO 14971, and FDA QSR while collaborating with cross-functional teams to deliver scalable, reliable medical devices.

The role emphasizes regulatory readiness, design verification/validation, supplier qualification, and audit support, with a focus on quality systems and risk-based

Qualifications

• Minimum 8+ years in Quality Engineering with 4+ years in electromechanical systems or software design.
• Solid understanding of design controls and risk management across product development lifecycle.
• Experience with medical standards such as ISO 13485, ISO 14971, and FDA QSRs.
• Ability to navigate quality systems with autonomy and drive.
• Strong risk-based decision making and cross-functional collaboration.

Responsibilities

• Plan and execute design controls, risk management, and design verification/validation for new products.
• Support DHF creation and ensure compliance with internal processes and external standards.
• Translate user needs into design while ensuring usability and regulatory compliance.
• Define design inputs/outputs and maintain traceability matrices with cross-functional teams.
• Contribute to risk management files and risk-based verification/validation strategies.
• Support supplier qualification, certification, and performance improvements.
• Participate in design and technical reviews and regulatory submissions.
• Assist in audits and interaction with auditors.

Skills

Design controls

Risk management

ISO 13485

FDA QSR

Electromechanical

Software life cycle

Traceability

Communication

Education

Bachelor's degree in STEM/engineering

Job description

Primary Function of Position

Senior Quality Engineer supports product development from concept through commercialization and will serve as the core team member for the cross-functional product development team. Senior Quality Engineer will provide expertise and guidance to the team on design control and risk management, Software Development Life Cycle, and Design for Reliability and Manufacturing. In addition, this position will play an effective role to ensure that the developed products meet quality standards consistent with Intuitive’s quality processes, while meeting all external design control and regulatory requirements. Essential Job Duties (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional managers.

• Proven contributor to the planning and execution of design controls, risk management, and design verification/validation for new products.


• Participate and support the development of product design history file and ensure compliance to internal processes and external standards and regulations.


• Understand user needs and assure they are translated to the design, while ensuring compliance to usability and human factors standards and regulations.


• Partner with engineering to define design inputs, design outputs, and traceability matrices.


• Contribute to the strategy and execution of risk-based design verification and validation.


• Participate and support the development of product risk management file, to analyze and assess the product risks associated with user, design, process and supplier.


• Ensure reliable and scalable designs to transferred to manufacturing.


• Review design architectures, selections, requirements, and drawings from early design.


• Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of scalable designs into production.


• Assist in supplier selection, qualification, certification, and performance improvement.


• Contribute to new product development Technical Reviews and Design Reviews.


• Support Regulatory Affairs with creating submissions and responding to submission questions.


• Support internal and external audits, including preparation and direct interaction with auditors.

Qualifications

Required Skills and Experience

• Minimum 8+ years of working experience in Quality Engineering, minimum 4 years in electromechanical systems and/or software design and development.


• Solid understanding of design control and risk management from early design and development through commercialization; demonstrated experience with electromechanical system from concept through launch is required.


• Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization.


• Able to navigate quality system with minimal oversight on personal projects.


• Balanced risk decision making to drive product quality, gain consensus, and work through technical challenges.


• Solves complex problem with minimal oversight.


• Able to articulate complex information to teams, including executive management.

Required Education and Training

• Education: Minimum bachelor’s degree in STEM, electrical, mechanical, system engineering, math, or physics.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic‑assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.