Intuitive
Healthcare
SeniorQualityEngineer-FutureForward/NPD
Neural analysis suggests this role is
optimal for mid candidates.
“Senior Quality Engineer - Future Forward / NPD at Intuitive. Skills: Quality Functional Leadership, Product Development Support, Design Controls Expertise, Risk Management Expertise, Process Validation Expertise, Design for Reliability and Manufacturing Expertise. Support projects associated with the development of next generation products. Support product development from concept through commercialization”
What You'll Achieve.
Ensure developed products meet quality standards consistent with Intuitive’s quality processes and all external design control and regulatory requirements; Drive product quality
Industry & Context.
Ability to solve complex problems with minimal oversight
May require current proof of vaccination against certain diseases including COVID-19, May be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status, Final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, 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
What They're Looking For.
Must Have
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, 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, Previous experience with running Verification & Validation Testing, 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
Nice to Have
Experience working with robotic or complex electromechanical devices, Previous experience with reliability principles, testing, reliability growth planning, and execution, Certifications such as ASQ CQE, ASQ CRE, or Six Sigma Black Belt
What You'll Do.
Support projects associated with the development of next generation products
Support product development from concept through commercialization
Serve as a core team member of the cross-functional product development team
Provide expertise and guidance on design controls
and design for reliability and manufacturing
Ensure developed products meet quality standards consistent with Intuitive’s quality processes and all external design control and regulatory requirements
Contribute to the planning and execution of design controls
and design verification/validation for new products
Participate in and support the development of the product design history file
ensuring compliance with internal processes and external standards and regulations
Understand user needs and ensure they are translated into the design
while complying with usability and human factors standards and regulations
Partner with engineering to define design inputs
and traceability matrices
Contribute to the strategy and execution of risk-based design verification and validation
Participate in and support the development of the product risk management file
analyzing and assessing product risks associated with user
Ensure reliable and scalable designs are transferred to manufacturing
Review design architectures
and drawings from early design stages
Collaborate with manufacturing
and supplier engineering to facilitate the transfer of scalable designs into production
Assist in supplier selection
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
Support continuous improvement in design control & risk management quality processes and methodologies
How You'll Work.
Team & Collaboration
Serve as a core team member of the cross-functional product development team; Partner with engineering to define design inputs, design outputs, and traceability matrices; Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate the transfer of scalable designs into production; Articulate complex information to teams, including executive management
Communication Scope
Ability to articulate complex information to teams, including executive management
Full Job Description
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. 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 Partici
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