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Lead Systems Engineer in Medical Technology

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 cutting-edge robotics and artificial intelligence. Founded by alumni from Stanford and MIT, who have a successful track record in the medical device sector, our flagship product employs a bespoke instrument combined with AI to autonomously prepare, image, and analyze tissue samples during biopsy procedures. We are backed by venture capitalists specializing in healthcare and deep technology, united in our mission to provide significant advancements in cancer patient care.

Opportunity Overview: We are seeking a highly skilled systems engineer to propel the advancement of our innovative tissue processing and analytical instruments. The ideal candidate will possess extensive experience in the development, validation, integration, testing, and commercialization of intricate automated instruments within the regulated medical industry. Familiarity with mechatronics, optics, and fluidic systems 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 the system architecture for new medical instruments
  • Contribute actively to system design and lead integration and testing initiatives
  • Establish performance requirements and metrics for subsystems
  • Collaborate with internal and external teams to develop, manage, implement, and verify system requirements
  • Ensure thorough documentation to support regulatory submissions
  • Work closely with a multidisciplinary engineering team and leadership to achieve critical technical milestones
  • Assemble, integrate, troubleshoot, and conduct verification and validation on instruments and consumables
  • Lead compliance testing efforts for regulated 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 product design, transfer, and launch
  • Ensure adherence to Quality Management Systems and Product Development Processes
  • Manage documentation and maintain traceability throughout the development process
  • Contribute to 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 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 skills 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 at our facility

Ruby Robotics is an equal opportunity employer committed to providing a safe environment for all employees, free from discrimination based on race, color, national origin, religion, sexual orientation, gender, gender identity and expression, age, veteran status, or disability.