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Senior Systems Engineer
1 month ago
Senior Systems Engineer: Ruby Robotics
About Us: Ruby Robotics is advancing precision oncology with robotics and artificial intelligence solutions. Started by Stanford/MIT alumni who previously founded 3 successful medical device companies, our first product uses a custom-built instrument and AI to autonomously prepare, image and analyze tissue during biopsy procedures. We are funded by healthcare and deep tech VCs that share our goal of offering impactful solutions to cancer patient care.
About This Opportunity: We are looking for an experienced systems engineer to advance the development of our novel tissue processing and analytics instruments. The ideal candidate will have a proven track record of developing, validating, integrating, testing and commercializing complex automated instruments in the regulated medical field. Knowledge in mechatronics, optics, and fluidics components is a plus, as well as experience writing design requirements, ensuring complete design outputs, and executing V&V plans. Must be open to working on-site at our facility in San Carlos, CA.
Responsibilities:
- Lead the definition of the system architecture for new medical instruments
- Actively contribute to system design and lead integration and test efforts
- Define sub-system performance requirements and their metrics
- Work with internal and external cross-functional team members to develop, manage, implement and verify system requirements
- Ensure complete documentation required to support FDA submissions
- Work closely with a multidisciplinary engineering team and company leadership to deliver on key technical milestones
- Assemble, integrate, troubleshoot and perform verification & validation on instruments and consumables
- Lead the effort to conduct 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 the design, transfer, and launch of products
- Ensure implementation of the QMS and PDP and their compliance
- Manage documentation and ensure traceability across the PDP
- Create new intellectual property
Qualifications:
- 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 that collaboration, trust, dedication, resilience, continuous improvement, ownership and accountability are the path to success
- Ability to work on-site at our San Carlos, CA facility
Ruby-Robotics is proud to be an equal opportunity employer. We are committed to offer a safe environment for our employees and do not discriminate based upon race, color, national origin, religion, sexual orientation, gender, gender identity and expression, age, veteran status, or disability.
