Lead Systems Engineer in Medical Robotics

1 week ago

San Mateo, California, United States Ruby Robotics Full time

Position: Senior Systems Engineer - Ruby Robotics

Company Overview: Ruby Robotics is at the forefront of enhancing precision oncology through the integration of robotics and artificial intelligence. Founded by alumni from Stanford and MIT, who have a history of launching successful medical device ventures, our pioneering product employs a custom-designed instrument combined with AI to autonomously prepare, image, and analyze tissue samples during biopsy procedures. Our funding comes from esteemed healthcare and deep tech venture capitalists who align with our mission to deliver transformative solutions in cancer patient care.

Opportunity Overview: We are seeking a seasoned systems engineer to propel the advancement of our innovative tissue processing and analytics instruments. The ideal candidate will possess a robust background in the development, validation, integration, testing, and commercialization of intricate automated instruments within the regulated medical sector. Familiarity with mechatronics, optics, and fluidics components is advantageous, along with experience in drafting design specifications, ensuring comprehensive design outputs, and executing verification and validation plans. The role requires a willingness to work on-site.

Key Responsibilities:

  • Define the system architecture for new medical devices
  • Contribute to system design and lead integration and testing initiatives
  • Establish performance requirements and metrics for subsystems
  • Collaborate with internal and external cross-functional teams to develop, manage, implement, and verify system requirements
  • Prepare thorough documentation to support regulatory submissions
  • Work closely with a multidisciplinary engineering team and company leadership to achieve critical technical milestones
  • Assemble, integrate, troubleshoot, and conduct verification and validation on instruments and consumables
  • Oversee compliance testing for regulated devices
  • Assist in planning and conducting animal labs and clinical trials
  • Develop and implement testing procedures and protocols for instruments
  • Engage with vendors, suppliers, and manufacturing teams throughout the design, transfer, and launch phases of products
  • Ensure adherence to Quality Management Systems and Product Development Processes
  • Manage documentation and maintain traceability throughout the product development lifecycle
  • Foster the creation of new intellectual property

Qualifications:

  • Degree in engineering, physics, or a related discipline; advanced degree preferred
  • Minimum of 3 years of relevant experience in specifying, building, and testing complex electromechanical instruments (a doctorate degree may substitute for 2 years of experience)
  • Demonstrated success in developing and commercializing FDA or CLIA-regulated devices/instruments
  • Experience in creating documentation and ensuring traceability from product requirements to final reports
  • Hands-on experience with strong analytical capabilities and a creative approach
  • Ability to thrive in a small, agile startup environment
  • Strong team player who values collaboration, trust, dedication, resilience, continuous improvement, ownership, and accountability as keys to success
  • Willingness to work on-site

Ruby Robotics is committed to being an equal opportunity employer. We strive to provide a safe environment for all employees and do not discriminate based on race, color, national origin, religion, sexual orientation, gender, gender identity and expression, age, veteran status, or disability.

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