- Expired: over a month ago. Applications are no longer accepted.
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 executiion 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.
- 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.
- 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.
- Strong organizational skills.
- Strong data analysis abilities.
- Comfortable performing repetitive tasks and/or motions.
- Must be able to lift a minimum of 10 lbs.
AddressSan Jose, CA
TechnologyView all jobs at Visby Medical