Senior Quality Engineer - Multiport Da Vinci

About the role

The Senior Quality Engineer plays a critical role in the product development lifecycle, supporting the cross-functional team from concept to commercialization. They are responsible for providing expertise and guidance on design control and risk management, ensuring compliance with internal processes and external standards and regulations.

Responsibilities

• Provide expertise and guidance on design control and risk management, Software Development Life Cycle, and Design for Reliability and Manufacturing.
• 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.
• Develop and maintain product risk management file to analyze and assess product risks associated with users, design, processes, and suppliers.
• Ensure reliable and scalable designs are transferred to manufacturing.
• Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate the transfer of scalable designs into production.
• Aid 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.

Qualifications

• Minimum 8+ years of working experience in Quality Engineering, minimum 4 years in electromechanical systems and/or software design and development.
• Strong understanding of design control and risk management from early design and development through commercialization.
• Demonstrated experience with electromechanical systems from concept through launch.
• 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 problems with minimal oversight.
• Able to articulate complex information to teams, including executive management.
• Education: Minimum bachelor’s degree in STEM, electrical, mechanical, system engineering, math, or physics.