Senior Design Assurance Engineer

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 and regulations.
    • Own trace closure from risks to requirements to testing
  • Submission/Audit
    • 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.

Skills:

• Able to understand technical design details.
• Able to navigate quality system with minimal oversight on personal projects.
• Able to generate, navigate and maintain complex network of documentation and requirement tracing.
• Balanced risk decision making to drive product quality, gain consensus, and work through technical challenges.
• Able to drive design changes based on risk mitigations, testing, and user needs.
• Solves complex problem with minimal oversight.
• Able to articulate complex information to teams, including executive management.

Experience, Education, & Training:

• Education: 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.

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.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

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.