San Jose based Visby Medical is an ambitious, well-funded, and fast-paced early stage biotech startup. Driven by a belief that disease diagnosis should be quick, accurate, and accessible to all, Visby is developing a novel diagnostic device platform that aims to redefine the way an infectious disease is tested and treated.

We are developing a tenacious team with deep industry expertise of researchers, biologists, designers, and engineers that is back-stopped by world class operations and administrative resources. If you enjoy tackling challenging problems, are passionate about your work product, and want to join a collaborative ownership team that is aiming to leave a lasting positive legacy in the healthcare industry, please consider the following Systems Engineer opportunity.

Summary

The Systems Engineer will support the Engineering team in the development of a diagnostic device. This candidate will be a strong individual contributor as well as providing guidance to more junior team members in the planning, development, and execution of Verification and Validation studies. This person should have at least 3 years of experience designing and executing V&V activities on a FDA regulated medical device. 

Essential Duties

Primary QMS Responsibilities:

  • Provide guidance and help with defining Design Requirements and Specifications on a novel, fully disposable PCR test.
  • Risk assessment and risk management.
  • Perform system, sub-system and component level characterization and functional testing.
  • Help develop and manage Design Verification Plans.
  • Design and execute Verification and Validation testing, writing test protocols and generating Test Reports.

Primary Non-QMS Responsibilities:

  • Drive product development through rigorous and comprehensive V&V testing.
  • Communicate with key stakeholders and help define scope and objectives of verification testing. Provide guidance throughout V&V process.
  • Interface with FDA and other regulatory bodies.
  • Perform biological and engineering experiments. 
  • Debug complex and interdependent biological and electromechanical subsystems.
  • Contribute to the definition and design of the system architecture.
  • Interfacing with vendors and generating DCOs.
  • Other duties as assigned.

Education and/or Experience

  • Bachelors or Masters of Science Degree in Bioengineering or related discipline.
  • 3-5 years work experience on a regulated medical device.
  • Hands on experience working with clinical samples, biohazardous material and infectious agents.
  • Experience working with PCR and ELISA based assays.

Other Qualifications

  • Strong hands-on experience troubleshooting biological and electromechanical systems.
  • Strong organizational skills. 
  • Strong data analysis abilities. 

Physical Demands

  • Comfortable performing repetitive tasks and/or motions.
  • Must be able to lift a minimum of 10 lbs.

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