Job Description
Primary Function of 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.
Essential Job Duties (Specific responsibilities and tasks an individual would be expected to
perform in the role. Additional job duties may be determined by functional managers.
Proven contributor to the planning and execution of design
controls, risk management, and design
verification/validation for new products
o Participate and support the development of product
design history file and ensure compliance to internal
processes and external standards and regulations.
o Understand user needs and assure they are translated to the design, while
ensuring compliance to usability and human factors standards and regulations.
o Partner with engineering to define design inputs, design outputs, and traceability
matrices.
o Contribute to the strategy and execution of risk-based design verification and
validation.
o 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
o Review design architectures, selections, requirements, and drawings from early
design
o Collaborate with manufacturing, purchasing, test engineering, and supplier
engineering to facilitate transfer of scalable designs into production.
o Assist in supplier selection, qualification, certification, and performance
improvement.
o 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.
Qualifications
Required Skills and Experience
• 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.
Required Education and Training
• Education: Minimum bachelor's degree in STEM, electrical, mechanical, system
engineering, math, or physics.
Additional Information
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate's experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate's qualifications, consistent with applicable law.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
