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Staff Systems Engineer

San Jose, CA

About Visby

Visby 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 Job

The Staff Systems Engineer will use their extensive experience to develop novel, fully disposable PCR-based diagnostic products. This position is for engineers with a thorough understanding of Systems Engineering precedents, practices, theories and principles who want to take a leadership role developing revolutionary diagnostics tests. This person will be a subject matter expert on an experienced team of Systems and Electrical Engineers working to develop Visby’s product portfolio.

How You’ll Make an Impact

As a key member of the Systems Engineering team, you’ll help Visby achieve it’s goals by:

  • Contributing directly to the development of Visby’s next generation platform by supporting subsystem characterization, device integration and functional testing.
  • Working with R&D, Engineering and other key stakeholders to refine design requirements on Visby’s next generation platform.
  • Refining system and subsystem level design specifications to ensure robust and reliable product performance that align with FDA and other regulatory guidelines
  • Developing and validating test methods to verify critical design specifications
  • Developing Verification test plans and managing execution. Coordinate system and sub-system pre-testing to ensure successful V&V results
  • Mentoring Systems Engineers
  • Contributing to Visby’s IP portfolio

On Your First Day We’d Like You to Have

  • At least 5 years of development experience in a highly regulated industry (medical, aerospace, etc.). Possess a thorough understanding of design controls, change controls and the product development process.
  • Experience taking at least one highly regulated product from the Feasibility stage through Verification and Validation
  • Experience developing and validating test methods
  • Working knowledge of Mechanical Engineering, Biology and Fluidics
  • Thorough understanding of precedents, practices, theories and principles of Systems Engineering
  • Experience with statistical process control (Minitab, JMP, etc.)
  • Demonstrated experience leading cross-functional teams through design reviews and risk management activities
  • Excellent communications skills

The following Educational Background:

  • B.S. Bioengineering, Mechanical Engineering or related field
  • 10-12 years of experience in industry with B.S. OR
  • 8-10 years of experience in industry with M.S OR
  • 5-7 years of experience in industry with Ph.D

It’s Great If You Have

  • Experience developing molecular diagnostic systems
  • Working knowledge of Injection Molding and Ultrasonic Welding
  • Working knowledge of ISO 13485, IEC 62304, and other FDA requirements
  • Master's degree or certification in Systems Engineering or related field
  • Wet lab experience

Salary range

  • $175,000 - $200,000 (Salary range for candidates based in San Jose, CA)
  • Compensation for the role is based on geographical location. 
  • 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.

More about our benefits

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.

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