BASIC QUALIFICATIONS:

• Education: Bachelor’s degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred

• 4+ years of working experience in Quality Engineering or related field, minimum 3 years in medical device design environment

• 2+ years of working experience in design control and risk management from early design and development through commercialization; Demonstrated experience with electromechanical systems.
• Experience with medical standards compliance, including ISO 13485, ISO 14971, IEC 60601, IEC 62304, and 21 CFR 820 with a focus on design controls and risk management.

PREFERRED QUALIFICATIONS:

• Experience with SaMD and SiMD is preferred

• Able to navigate the quality system with minimal oversight on individual projects.

• Balanced risk decision making to drive product quality, gain consensus, and work through technical challenges.
• Solves complex problems with minimal oversight.
• Able to articulate complex information to teams, including executive management.

WHAT YOU’LL LOVE ABOUT US

• Inclusive healthcare and benefits: On top of comprehensive medical, dental, and vision coverage, we offer employees and their family members help with gender-affirming care, tools for family and fertility planning, and travel reimbursements if healthcare isn’t available where you live.
• Planning for the future: Start saving for the future with our traditional or Roth 401k retirement plan options which include a 2% company match.
• Modern life stipends: Manage your own learning and development

The Sr Design Quality Engineer supports product development from concept through commercialization and will serve as the core team member for the cross-functional product development team. Sr Design Quality Engineer will provide subject matter expertise and guidance to the team on design control and risk management from early development through design transfer, Design for Reliability and Manufacturing, product Development Life Cycle, and Process Validation. In addition, this position will play a working 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.
What You’ll Accomplish:
-

Design Control and Risk Management Stewardship: Planning and execution of design controls, risk management, and design verification/validation for new products

• Advocate product design history file and ensure compliance to internal processes and external standards and regulations.
• Understand user needs and assure they are translated to the design, while ensuring compliance to 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.
• Accountable for overall risk management file: participate and support the development of product risk management file, to analyze and assess the product risks associated with user, design, process and supplier.
• Review and provide feedback on design architectures, selections, requirements, and drawings from early design
• Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of scalable designs into production.
• Contribute to new product development Technical Reviews and Design Reviews.
• Support Regulatory Affairs with creating submissions and responding to submission questions.
• Perform and/or support audits (internal, external, and by regulatory agencies)
• Coach, mentor, teach, and influence the engineering staff in best quality practices, data analysis, protocol development, and design for quality and reliability methods