Staff Quality Engineer (Design Controls / Risk Management / Class III)

Intuitive • Sunnyvale, CA

273d • $170,000 - $244,600 • Onsite

About The Position

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Requirements

• Bachelor's degree in electrical, mechanical or system engineering, math, or physics; Advanced degree preferred
• 12+ years of working experience in Quality Engineering or related field, minimum 6 years in medical device design environment
• Advanced expertise of design control and risk management from early design and development through commercialization
• Demonstrated experience with electromechanical system
• Experience with Class III devices & early clinical studies is preferred
• 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 individual 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

Responsibilities

• 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
• Support design controls activities supporting clinical studies
• Advocate and ensure the transfer of reliable and scalable designs to manufacturing
• 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
• 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
• 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 to 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree