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Senior Systems Engineer
2 months ago
Ruby Robotics is a pioneering company in the field of precision oncology, leveraging robotics and artificial intelligence to revolutionize cancer patient care. Founded by visionary alumni from Stanford and MIT, our mission is to deliver impactful solutions that make a meaningful difference in people's lives.
Job OpportunityWe are seeking an experienced Senior Systems Engineer to join our team and contribute to the development of our novel tissue processing and analytics instruments. As a key member of our engineering team, you will play a critical role in advancing the design, integration, and testing of our complex automated instruments.
Responsibilities- Lead the definition of system architecture for new medical instruments
- Contribute to system design and lead integration and test efforts
- Define sub-system performance requirements and their metrics
- Collaborate with cross-functional teams to develop, manage, implement, and verify system requirements
- Ensure complete documentation for FDA submissions
- Work closely with engineering teams and company leadership to deliver on key technical milestones
- Assemble, integrate, troubleshoot, and perform verification & validation on instruments and consumables
- Lead compliance testing for regulated devices
- Support planning and conduct animal labs and clinical trials
- Create and implement procedures and protocols for instrument testing
- Collaborate with vendors, suppliers, and manufacturing personnel throughout design, transfer, and launch of products
- Ensure implementation of QMS and PDP and their compliance
- Manage documentation and ensure traceability across PDP
- Create new intellectual property
- Degree in engineering, physics, or related field. Advanced degree preferred
- Minimum 3 years relevant experience specifying, building, and testing complex electromechanical instrumentation (doctorate degree substitutes for 2 years experience)
- Proven record in successfully developing and commercializing FDA or CLIA-regulated device/instruments
- Experience developing documentation and ensuring traceability from product requirements to final reports
- Hands-on with strong analytical skills and a creative mindset
- Works well in a small agile startup team
- Strong team player who believes in collaboration, trust, dedication, resilience, continuous improvement, ownership, and accountability
- Ability to work on-site at our San Mateo CA facility
Ruby-Robotics is an equal opportunity employer, committed to providing a safe and inclusive environment for our employees. We do not discriminate based on race, color, national origin, religion, sexual orientation, gender, gender identity and expression, age, veteran status, or disability.