Staff Quality Engineer

Intuitive•San Francisco, CA

About The Position

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 proven quality functional leader to support the projects associated with the development of next generation innovation products. The Staff Quality Engineer supports product development from concept through commercialization and will serve as the core team member for the cross-functional product development team. Staff 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.

Requirements

Education: Bachelor’s degree in electrical, mechanical, biomedical or system engineering, math, or physics.
12+ years of working experience in Quality Engineering or related field, minimum 6 years in medical device design environment specifically with Class II or Class III products.
Advanced expertise in design control and risk management from early design and development through commercialization and demonstrated experience with electromechanical systems.
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 systems with minimal oversight on individual projects.
Balanced risk decision making to drive product quality, gain consensus, and work through technical challenges.
Able to articulate complex information to teams, including executive management.

Nice To Haves

Advanced degree preferred.
Experience working with Energy Delivery products (e.g. Mapping Catheters, RF Ablation, Pulsed Field Ablation etc.).

Responsibilities

Planning and execution of design controls, risk management, and design verification/validation for new products
Advocate product design history file and ensure compliance with internal processes and external standards and regulations.
Understand user needs and assure they are translated to the design, while ensuring compliance 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.
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.
Support design controls activities associated with new product development.
Advocate and ensure the transfer of reliable and scalable designs to manufacturing
Review and provide feedback on design architecture, 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.
Author CAPAs to ensure implementation of timely and effective corrective & preventive actions.
Perform and/or support audits (internal, external, and by regulatory agencies).
Provide quality engineering support for the company’s contract manufacturing operations.
Coach, mentor, teach, and influence the engineering staff in best quality practices, data analysis, protocol development, and design for quality and reliability methods.