Senior Design Assurance Engineer

Intuitive • Sunnyvale, CA

89d

About The Position

Intuitive Surgical designs and manufactures highly complex surgical systems including cameras, instruments, and accessories for use in surgery. We are looking for an exceptional individual to join the New Product Development Department to support the development of next generation innovation products. Design Assurance Engineer supports product development from concept through commercialization and will serve as a core team member for the cross-functional product development team. The individual will have expertise to drive and own hardware and software design controls and risk management elements, in order to promote rigor and robust design to meet requirements for Safety, Reliability and Manufacturability. In addition, this position will ensure developed products and documentation meet quality standards consistent with Intuitive's quality processes, while meeting all external design control and regulatory requirements.

Requirements

• Minimum bachelor's degree in electrical, mechanical or system engineering, math, or physics.
• Minimum 8+ years, or equivalent with a Master or PhD degree, of working experience in Quality Engineering, Systems Engineering, Design Engineering or Design Assurance, including solid medical device experience in mechanical / electromechanical systems and software design.
• Solid understanding and experience of design control, risk management and design V&V from early design and development through commercialization as described in ISO 13485, ISO 14971 and FDA Quality System Regulations.
• Demonstrated experience with electromechanical system.
• Experience influencing the design teams processes and practices to enhance design rigor.

Responsibilities

• Proven contributor to the planning and execution of design controls, risk management, and design verification/validation for new products and launched products.
• Support user needs development and ensure they are translated to the design, while ensuring compliance to usability and human factors standards and regulations.
• Drive definitions of design inputs, design outputs, and associated thresholds in partnership with the cross-functional team.
• Ensure design output specifications are suitable for internal and external manufacturing, and process specifications are sufficient to meet design requirements.
• Ensure process specifications are robust for quality and manufacturability.
• Support Predicate Device Analysis to inform necessary requirements for new products.
• Contribute to new product development Technical Reviews and Design Reviews.
• Serve as technical interface between multiple engineering disciplines and subsystem teams to ensure related upstream/downstream requirements are in sync.
• Inform design decisions based on documented product risks, requirements and design control strategy.
• Own the development of risk documentation and assess the product risks associated with user and/or design.
• Make sure design is sufficiently mitigating risks through adequate requirements/specifications and effectiveness confirmation in V&V testing.
• Own risk documentation architecture to support cross-platform / system utilization and flexibility.
• Contribute to the strategy and execution of risk-based design verification and validation.
• Support the test teams to make sure test methods are relevant and appropriate for the specific design requirements / specifications / statistical analysis.
• Ensure design robustness by supporting limit challenge testing.
• Ensure system compatibility with internal and external parts by supporting integration testing.
• Participate and support the development of product design history file and ensure robustness, completeness and compliance to internal processes, external standards and regulations.
• Own trace closure from risks to requirements to testing.
• Support Regulatory Affairs with creating submissions, responding to submission questions and triaging to appropriate functions.
• Support internal and external audits, including preparation and direct interaction with auditors.

What This Job Offers

• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree