Lead Systems Engineer in Medical Robotics

2 months 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 innovative robotics and artificial intelligence technologies. Founded by alumni from Stanford and MIT, who have successfully launched multiple medical device companies, our flagship product employs a unique instrument combined with AI to autonomously prepare, image, and analyze tissue samples during biopsy procedures. We are backed by venture capitalists focused on healthcare and deep technology, all aligned with our mission to provide transformative solutions for cancer care.

Opportunity Overview: We are seeking a highly skilled systems engineer to propel the advancement of our cutting-edge tissue processing and analytical instruments. The ideal candidate will possess a strong history of developing, validating, integrating, testing, and commercializing intricate automated devices within the regulated medical sector. Familiarity with mechatronics, optics, and fluid dynamics is advantageous, along with experience in drafting design specifications, ensuring comprehensive design outputs, and executing verification and validation plans. The role requires on-site collaboration at our facility.

Key Responsibilities:

  • Define and lead the system architecture for innovative medical devices.
  • Contribute actively to system design and spearhead integration and testing initiatives.
  • Establish performance requirements for subsystems and their corresponding metrics.
  • Collaborate with internal and external cross-functional teams to develop, manage, implement, and verify system requirements.
  • Ensure 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 perform verification and validation on instruments and consumables.
  • Lead compliance testing efforts for regulated medical devices.
  • Support the planning and execution of animal labs and clinical trials.
  • Develop and implement testing procedures and protocols for instruments.
  • Engage with vendors, suppliers, and manufacturing teams throughout the product design, transfer, and launch phases.
  • Ensure adherence to Quality Management Systems and Product Development Processes.
  • Manage documentation and maintain traceability throughout the product development lifecycle.
  • Contribute to the creation of new intellectual property.

Qualifications:

  • Bachelor's degree in engineering, physics, or a related discipline; advanced degree preferred.
  • A minimum of 3 years of relevant experience in specifying, constructing, and testing complex electromechanical instrumentation (a doctorate 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.
  • A collaborative mindset suited for a small, agile startup environment.
  • A strong team player who values collaboration, trust, dedication, resilience, continuous improvement, ownership, and accountability as keys to success.
  • Willingness to work on-site at our facility.

Ruby Robotics is an equal opportunity employer, committed to providing a safe workplace for all employees and does 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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