Senior Quality Engineer

Company Description

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.

Job Description

Primary Function of Position The 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, Design for Reliability and Manufacturing, product Development Life Cycle, and Process Validation. 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.

Essential Job Duties

• Engage and manage multi-level and multi-discipline project work teams

• Develops and implement projects to achieve targets and tracks progress against schedules; and communicates status to management

• Provide support and expertise in the implementation and enforcement of GMP, ISO and FDA requirements

• Proficiency with pFMEAs, Test Method Validations, Root Cause, CAPAs, Non-Conformance Management, and Process Validation

• Proficiency with advanced data analysis tools and statistical methods (i.e., ANOVA, DOE, etc.)

• Provide statistical support and analytical problem solving for manufacturing, technical services, and product development to identify root cause of problems

• Experience with computerized systems, such as SAP, Trackwise, Agile, etc.

• Experience in product design changes, manufacturing changes, supplier changes and the associated requirements to execute such changes

• Outstanding organizational, communication, presentation, and interpersonal skill

• Solid contributor to the planning and execution of design controls, risk management, and design verification/validation for new products

• Ensure reliable and scalable Designs to transferred to manufacturing by supporting Design for Reliability and Manufacturing activities.

• Support Regulatory Affairs with creating submissions and responding to submission questions.

• Support internal and external audits, including preparation and direct interaction with auditors.

Qualifications

Required Skills and Experience

• Minimum Education: Bachelor’s in engineering or STEM

• Advanced degree preferred with minimum 6 years of working experience in Quality Engineering or related field, minimum 5 years in medical device design environment.

• 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

Required Education and Training