Company Description

Headquartered in San Francisco, CA, Cytovale is a dynamic, late-stage startup focused on developing a faster, more insightful way to diagnose fast-moving and immune-mediated diseases. Cytovale’s IntelliSep test is pioneering a new way of quickly and accurately analyzing white blood cells to stratify a patient’s risk of sepsis. The test simply and clearly determines risk of sepsis using a biomechanical evaluation of white blood cells collected from a standard blood draw, generating results in under 10 minutes. This gives physicians actionable information when they need it most, allowing them to confidently triage suspected sepsis patients quickly and spend more time with those in greatest need. It also helps strained health systems prevent unnecessary treatment, preserve valuable resources, and improve compliance with Sep-1 guidelines.

More information at cytovale.com and watch our IntelliSep video!

We are hiring a Mechanical Engineer II

Responsibilities

• Support new product development and new product introduction activities for the Cytovale System. Responsibilities include instrument reliability updates, DFX improvements, verification test support, and development of next generation instruments.
• Design and implement instrument updates to improve instrument reliability and manufacturability.
• Generate and maintain 3D models and drawings for design and sustaining of the Cytovale System.
• Improve requirements and test methods to improve instrument functionality and verification strategy.
• Work cross functionally with engineering and quality assurance teams to improve product design and facilitate instrument automation.
• Hands-on design: develop, test, and document across Cytovale’s in-vitro diagnostic device design against requirements. 
• Design, prototype, and test new features and improvements for Cytovale System.
• Assist with management of device requirements and FMEA/risk analysis (ISO 14971).
• Apply IEC 60601-1-2 and IEC 61010 safety standards.
• Perform role function in compliance with Cytovale’s QMS (ISO 13485). 

Qualifications

• Bachelor's Degree in Mechanical Engineering or a related Science with 3-7 years of product development experience is required.
• 2 years working on medical devices or other highly regulated products is preferred. 
• Experience in electro-mechanical medical devices and/or diagnostic equipment design and verification is preferred.
• Expertise in 3D CAD design and mechanical drawings.
  • Proficiency in Onshape and/or Solidworks is preferred
  • Competency in GD&T is required
• Statistical analysis related to verification or validation activities preferred. 
• Technical interest to become proficient in assay and instrument troubleshooting.

Requirements

• This position will be based in the San Francisco Bay Area.
• Ability to work in the United States.
• Role is 3 to 4 days per week onsite to carry out role functions. Up to 10% domestic travel.

Additional Details

• The compensation plan includes a generous base salary, a yearly cash bonus based on corporate and individual goal attainment, and an equity stake in the organization.
• Cytovale has a mandatory COVID-19 vaccination policy.

Who you are

• Excellent communicator, detail-oriented, and an avid GDP/GLP laboratory practitioner
• Fast-learner with a “can-do” attitude and an ability to work independently.
• Desire to work in a high velocity startup where collaboration is prized.