Senior Mechanical Engineer

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.

We are hiring a Senior Mechanical Engineer

Responsibilities

• Support advanced engineering activities for the Cytovale System. Responsibilities include support of reliability design improvements, design for manufacture, and instrument sustaining.
• Hands-on design: develop, test, and document across Cytovale’s in-vitro diagnostic device design against requirements.
• Provide detailed review of technical documents, including mechanical drawings and tolerance analysis.
• Oversee generation and maintenance of 3D models and drawings using Onshape for design and sustaining of the Cytovale System.
• (Technical) Project leadership. Ability to lead projects and provide guidance on technical priorities / plans.
• Develop organizational technical processes to improve team efficiency and build team capabilities.
• Improve requirements and test methods to improve instrument functionality and verification strategy
• Work cross functionally with electrical engineering, systems engineering, manufacturing, and quality assurance teams to improve product design.
• Assist with management of device requirements and FMEA/risk analysis (ISO 14971).
• Perform role function in compliance with Cytovale’s QMS (ISO 13485).

Qualifications

• Bachelor's Degree in Mechanical Engineering or a related Science.
• 7 years of medical device product development, or equivalent industry, experience required.
• Experience in electro-mechanical medical devices and/or diagnostic equipment design and verification is required.
• Expertise in 3D CAD design and mechanical drawings.
  • Proficiency in Onshape and/or Solidworks is preferred
  • Competency in GD&T is required
• Proficient with tolerance analysis
• Statistical analysis related to data analysis and verification 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 80% 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.