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.
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.
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.
Strong hands-on experience troubleshooting biological and electromechanical systems.