Senior Quality Engineer

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.

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 employeeswho 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 governments 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 employeesstart 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 candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates 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.

Remote Work :

No

Employment Type :

Full-time