Sr. QE Engineer

Intuitive•Sunnyvale, CA

2d•$127,600 - $215,900•Onsite

About The 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.

Requirements

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.
Minimum bachelor’s degree in STEM, electrical, mechanical, system engineering, math, or physics.

Responsibilities

Proven contributor to the planning and execution of design controls, risk management, and design verification/validation for new products
Participate and support the development of 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.
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
Review 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.
Assist in supplier selection, qualification, certification, 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.