Staff Mechanical Engineer
Visby Medical
Other Engineering
San Jose, CA, USA
Posted on May 9, 2025
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 Role
The Staff Mechanical Engineer will be a key contributor in the design and development of disposable medical diagnostic devices. This candidate will have a proven track record of developing medical devices and bringing them to market. This candidate will excel in a dynamic and exciting workplace environment.
How You'll Make An Impact
- QMS responsibilities
- Design and develop parts and modules in the creation of novel diagnostic molecular test products.
- Define design requirements, specifications, and drawings to ensure product function.
- Transfer design to manufacturing and vendor selection to support high volume scale up.
- Lead contributor during design development process, providing input to DHF, and leading informal and formal design reviews
- Perform or supervise others to perform experiments to verify mechanical and/or assay performance.
- Non - QMS responsibility
- Research through concept development, prototype, or analysis candidate designs or methods for future products.
- Performing necessary analysis to ensure proper product function. FEA, Tol stacks, etc.
- Contribute to grant writing activities
- Write patent disclosures
- Other duties as assigned.
On Your First Day We’d Like You to Have
- BS in Bioengineering or Mechanical Engineering. MS preferred.
- Greater than 7 years of experience in the development of medical devices.
It’s Great If You Have
- Expert mechanical designer using Solidworks. 3D and 2D. GD&T ASME Y 14.5M - 1994
- Extensive experience in the design of precision injection molded components and elastomers for high volume and low cost production of medical devices
- Experience with products that perform precise fluid handling.
- Knowledge of design control process for the development of class 2 medical device.
- Test method development and validation
- Excellent communicator, verbal and written
- Demonstrated ability to work effectively under pressure, while maintaining the highest ethical
- Demonstrated ability to hold highest ethical standards, serving as a role model both within and outside of the company.
More about our benefits
Visby offers highly competitive health insurance through United Healthcare or Kaiser, including a company-funded HSA option. We also offer 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.