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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!

The Staff Hardware Reliability and Test Engineer will be a key architect for Cytovale’s next generation instrumentation. They will work closely with other New Product Development Engineers (Mechanical, Electrical, Systems, and Software) to design an integrated instrument with enhanced user experience through the incorporation of automation and DFX features. The position will coordinate and execute a hardware test strategy to drive instrument reliability improvements throughout the product development process. This position will lead the drafting of hardware test protocols, design of fixtures, coordination of test executions, and analysis of data to quantify and improve instrument reliability. Test activities will begin in feasibility and continue throughout development and V&V. This role reports to senior engineering leadership.

Responsibilities

• Define and direct hardware test strategy for the next generation Cytovale System.
• Prioritize and execute hardware test activities from conceptualization through new product introduction.
• Develop and track sub-system and instrument reliability performance metrics.
• Collaborate with the New Product Development team to realize an improved and more reliable instrument design. Key partners include Mechanical, Electrical Engineering, and Systems Engineering.
• Interface directly with design partners and contract manufacturers to facilitate effective completion of engineering activities.
• Provide input on key technical decisions based on previous experience in the IVD or medical device space.
• Develop and validate robust verification test protocols.
• Design and validate test fixtures. Leverage sensors, electrical instrumentation, and mechanical fixturing to quantify instrument performance.
• Maintain project plans, budgets, and sprint plans throughout the development process.
• Manage internal and external hardware project contributors.
• 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, Electrical Engineering, or a related Science/Engineering field with 7+ years of experience with complex electromechanical instrumentation. Desired: 5+ medical device or regulated product development design experience, or equivalent industry experience.
• Successful history of supporting a product from feasibility through product launch within a 21 CFR Part 820 compliant quality management system.
• Familiarity with quantitative hardware test development and verification activities.
• Extensive knowledge of complex fluidic electro-mechanical and opto-mechanical systems
• Proficiency with data analysis tools (R, Python, and/or Minitab)
• Strong technical capabilities and a hands-on working style.
• Experience applying concurrent design principles during feasibility and development.
• Preferred: Familiarity with 3D CAD (Onshape and/or Solidworks) and mechanical drawing generation including competency in GD&T.
• Preferred: Experience in mechanical modeling and analysis including FEA and tolerance analysis.
• Preferred: Proficiency programming experience in Python, Labview, and/or C++.
• Prefered: Knowledge of instrument electrical architectures and best practices to develop instruments to meet IEC 60601-1-2 and IEC 61010 EMC/EMC standards.

Requirements

• This position will be based in the San Francisco Bay Area.
• Ability to work in the United States.
• Role is up to 4 days per week onsite to carry out role functions. Up to 20% domestic travel.

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.
• You have a passion for our mission and believe that what we are building is innovative enough to change the world.
• You thrive in a fluid environment, are comfortable with ambiguity and can shift gears quickly.

At Cytovale, we are an extraordinary team of biologists, data scientists, engineers, quality, clinical and just plain caring people with a vision for how to make very complex, critical diseases come into sharp and present focus. We will never stop working together and striving to make our technology stronger, faster, and easier-to-implement so that every person who arrives for medical care is quickly screened and appropriately treated for fast-moving diseases while there is still time to act.

Cytovale offers a total rewards package that includes a generous base salary, annual cash bonus based on corporate and individual goal attainment, and an equity stake in the organization. We have a mandatory COVID-19 vaccination policy, casual work environment, a diverse and inclusive culture, and an electric atmosphere for professional development. Qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, gender expression, veteran status, or disability.