- Lead the development and documentation of engineering design specifications for Visby platforms, ensuring proper device function and interaction with a Computer Vision / Machine Learning (Artificial Intelligence) module deployed on Apple and Android phones.
- Design and execute Verification and Validation testing, writing test protocols and generating test reports
- Develop and validate methods used to test and verify system and component level requirements
- Debug complex and interdependent biological and electromechanical subsystems
- Perform system, sub-system and component level characterization and functional testing
- Lead compliance testing to applicable safety standards (IEC 60601, IEC 61010, etc.)
- Risk assessment and risk management. Work with Quality group to develop and maintain risk analysis documentation to ensure Visby products are safe for use in their intended environments.
- Generating DCO's, managing BOMs and interfacing with vendors.
- Other duties as assigned
- B.S., Electrical Engineering, Bioengineering, Mechanical Engineering or related field
- 3-5 years of experience in industry with B.S. OR
- 0-2 years of experience in industry with M.S
- Thorough understanding of Systems Engineering theory and underlying principles.
- $100,496 - $125,620 (salary range for candidates based in San Jose)
- Compensation for the role is based on geographical location. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly.
- Compensation also depends on a number of factors including a candidate's qualifications, skills, competencies and experience and may fall outside of the range shown.
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Systems Engineer - San Jose, United States - Visby Medical
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Description
About VisbyVisby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the world's first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.
About the role
The Systems Engineer will use their skill and experience to develop novel, fully disposable PCR-based diagnostic products. This position is for mid- level engineers who are eager to broaden their Systems Engineering skillset while working on revolutionary diagnostics tests. This person will work closely with an experienced team of Systems and Electrical Engineers to develop Visby's product portfolio.
How you'll make an impact
Visby offers highly competitive health insurance through Cigna or Kaiser, including a company-funded HSA option. We also offer a 401k match, flexible paid time off, 11 company holidays, and many other contemporary benefits and perks.
Visby is a proud recipient of the 2023 Cigna Healthy Workforce Designation.
Additional information
We believe that the unique contributions of all Visbees is the driver of our success. To make sure that our products and culture continue to incorporate everyone's perspectives and experience we never discriminate on the basis of race, color, religion, creed, national origin, ancestry, sex, gender, pregnancy or related medical conditions, sexual orientation, gender identity or expression, age, disability, medical condition, genetic information, marital status, or military or veteran status.
Full COVID Vaccination Required - Reasonable accommodations for medical or religious reasons considered.