Senior Quality Engineer (Design Control and Risk Management)

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:
  • 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.

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 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 experience with running Verification & Validation Testing is preferred.
• 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.