Systems Engineer II
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
WHAT WILL YOU WORK ON?
The Systems Engineer II works directly with Project Management and other Engineers (software, hardware, mechanical, electrical engineers and testers) to improve the current design and troubleshoot issues, and work on potential new designs. Additionally, the Systems Engineer works with Marketing, Quality, Service and Manufacturing team members throughout the design process. This role reports to the Systems Engineering lead.
- Manage the execution of engineering deliverables associated with the development of IVD products including the support of deliverables for regulatory submissions.
- Hands-on design verification: Define verification test approaches (software and hardware) against requirements and translate them into test protocols for Cytovale's in-vitro diagnostic device.
- Develop & update requirements at system, instrument and component levels for improved testability and functionality.
- Select and apply appropriate statistical approach to verification or validation activities.
- Contribute to impact analysis of design changes.
- Contribute to process improvements, including risk management and design control.
- Contribute to Risk management activities including FMEA and risk analysis (ISO 14971).
- Assist with test tools, test method and tool validation.
- Assist with troubleshooting and incident investigations.
- Perform role function in compliance with Cytovale’s QMS.
- Other duties as assigned.
- Bachelor's Degree in Engineering or a related Science with at least 2 years of medical device product development test/verification experience, or equivalent industry experience, required.
- Experience in electro-mechanical medical devices or diagnostic equipment verification.
- Experience in one of the following areas:
- Experience developing test plans, requirements, and risk management documents.
- Expertise in design for manufacturing and/or IQ/OQ/PQ.
- Expertise in reliability and/or automation desired
- Knowledge of regulatory standards such as CFR 820, ISO 14971, ISO 13485, IEC 62304.
- A strong desire to work in a small, fast-paced environment of a late-stage startup.
- Ability to work in the United States.
- This position will be based in the San Francisco Bay Area.
- Role is 3-4 days per week onsite to carry out role functions.
- Some travel is required (up to 25%).
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.
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