Senior Quality Engineer Multiport Da Vinci

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
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
o Participate and support the development of product
design history file and ensure compliance to internal
processes and external standards and regulations.
o Understand user needs and assure they are translated to the design while
ensuring compliance to 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 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
o Review design architectures selections requirements and drawings from early
design
o Collaborate with manufacturing purchasing test engineering and supplier
engineering to facilitate 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.
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 bachelors degree in STEM electrical mechanical system
engineering math or physics.

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