Intuitive Surgical

Intuitive Surgical

Senior Quality Engineer - Multiport Da Vinci

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Role

Senior Quality Engineer - Multiport Da Vinci

Job type

Full-time

Posted

Yesterday

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Salary

Not disclosed by employer

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

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.

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.

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