Senior Design Assurance 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:

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.

Roles & Responsibilities:

• Proven contributor to the planning and execution of design controls, risk management, and design verification/validation for new products and launched products.
  • Requirements / Specifications development
    • 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.
  • Risk management
    • 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
  • Testing
    • 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
  • DHF Management
    • Participate and support the development of product design history file and ensure robustness, completeness and compliance to internal processes, external standards an