Sr. Quality Engineer

Sr. Quality Engineer (Finance)

Company

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.

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.

• Design Controls and Risk Management
  • Contribute to the planning and execution of design controls, risk management, 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, design outputs, 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, design, process, and supplier.
• Design Transfer
  • Ensure reliable and scalable designs are transferred to manufacturing.
  • Review design architectures, selections, requirements, and drawings from early design stages.
  • Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate the transfer of scalable designs into production.
  • Assist in supplier selection, qualification, certification, and performance improvement.
  • Contribute to new product development Technical Reviews and Design Reviews.
• Regulatory Support
  • Support Regulatory Affairs with creating submissions and responding to submission questions.
  • Support internal and external audits, including preparation and direct interaction with auditors.
• Process Improvement & Cross-Functional Collaboration
  • Support continuous improvement in design control & risk management quality processes and methodologies.

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 5 years of relevant experience and an Advanced Degree
• Expertise in medical device standards such as ISO 14971, IEC 60601, IEC 62304, ISO 80002-1, and FDA Design Controls. Previous experience risk-based V&V, process validation, limit/challenge testing is required
• Previous experience with reliability principles, testing, reliability growth planning, and execution is preferred
• Previous…