Full Job Description
Primary Function of Position:
Intuitive Surgical designs and manufactures highly complex surgical systems including
cameras, instruments, and accessories for use in surgery. We are looking for a strong
quality functional leader to support the projects associated with the development of next
generation products.
The Quality Engineer supports product development from concept through
commercialization and serves as a core team member of the cross-functional product
development team. This role provides expertise and guidance on design controls, risk
management, process validation, and design for reliability and manufacturing.
Additionally, the position ensures that developed products meet quality standards
consistent with Intuitive's quality processes and all external design control and regulatory
requirements.
Roles & Responsibilities:
Design Controls and Risk Management:
o Contribute to the planning and execution of design controls, risk management,
and design verification/validation for new products.
o Participate in and support the development of the product design history file,
ensuring compliance with internal processes and external standards and
regulations.
o Understand user needs and ensure they are translated into the design, while
complying with usability and human factors standards and regulations.
o Partner with engineering to define design inputs, design outputs, and traceability
matrices.
o Contribute to the strategy and execution of risk-based design verification and
validation.
o Participate in and support the development of the product risk management file,
analyzing and assessing product risks associated with user, design, process, and
supplier.
Design Transfer:
o Ensure reliable and scalable designs are transferred to manufacturing.
o Review design architectures, selections, requirements, and drawings from early
design stages.
o Collaborate with manufacturing, purchasing, test engineering, and supplier
engineering to facilitate the transfer of scalable designs into production.
o Assist in supplier selection, qualification, certification, and performance
improvement.
o Contribute to new product development Technical Reviews and Design Reviews.
Regulatory Support:
o Support Regulatory Affairs with creating submissions and responding to
submission questions.
o Support internal and external audits, including preparation and direct interaction
with auditors.
Process Improvement & Cross-Functional Collaboration
o Support continuous improvement in design control & risk management quality
processes and methodologies.
Qualifications
Qualifications
Skills, Experience, Education, & Training:
Requires a minimum of 8 years of related experience with a University Degree (in
Electrical Engineering, Mechanical Engineering, Computer Science, software engineering,
biomedical engineering), or 6 years of relevant experience and an Advanced Degree.
Strong proficiency in FDA Design Controls and international standards, including ISO
13485, ISO 14971, and IEC 60601/62304. Previous experience with risk-based V&V,
process validation, and limit/challenge testing are required.
Experience working with robotic or complex electromechanical devices is preferred.
Previous experience with reliability principles, testing, reliability growth planning, and
execution is preferred
Previous experience with running Verification & Validation Testing is required.
Ability to navigate quality systems with minimal oversight on individual projects.
Balanced risk decision-making to drive product quality, gain consensus, and work through
technical challenges.
Ability to solve complex problems with minimal oversight. Ability to articulate complex
information to teams, including executive management.
Certifications such as ASQ CQE, ASQ CRE, or Six Sigma Black Belt are preferred.
Additional Information
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.
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.
