Senior Manager, Hardware Engineering
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!
WHAT WILL YOU WORK ON?
The Senior Manager, Hardware Engineering will be a key architect for Cytovale’s next generation instrumentation. They will work closely with other New Product Development Engineers (Software, Electrical, and Systems) to design an integrated instrument with enhanced user experience through the incorporation of automation and DFX features. The position will coordinate internal hardware development activities, while also working closely with external partners and collaborators. Initially, this position will lead hands-on sub-system hardware feasibility and prototyping, followed by progression into development, V&V, and NPI activities. This role reports to senior engineering leadership.
- Define and direct hardware architecture for the next generation Cytovale System.
- Manage and prioritize hardware engineering activities from conceptualization through new product introduction.
- Collaborate with the New Product Development team to realize an improved and more reliable instrument design. Key partners include Software and Electrical Engineering, Systems Engineering, Hardware Test, Manufacturing, and Service.
- Brainstorm and prototype concepts to improve upon current system performance and generate intellectual property.
- 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. Review mechanical or electrical drawings (including GD&T) and 3D CAD. Select electro-mechanical components to meet design requirements.
- Support development of robust verification test fixtures and protocols.
- 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).
- Bachelor's Degree in Mechanical 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.
- Experience managing teams with 5+ contributors.
- Strong technical capabilities and a hands-on working style.
- Successful history of supporting a product from feasibility through product launch within a 21 CFR Part 820 compliant quality management system.
- Extensive knowledge of complex fluidic electro-mechanical and opto-mechanical systems.
- Experience with manufacture and production processes including CNC machining, sheet metal forming, and injection molding (including RIM).
- Familiarity with quantitative hardware test development and verification activities.
- Proficiency in 3D CAD (Onshape and/or Solidworks) and mechanical drawing generation including competency in GD&T.
- Experience applying concurrent design principles during feasibility and development.
- Preferred: Proficiency with test fixture design and development.
- Preferred: Familiarity programming experience in Python, Labview, and/or C++ for electro-mechanical instrument prototyping and test fixture design.
- Prefered: Knowledge of instrument electrical architectures and best practices to develop instruments to meet IEC 60601-1-2 and IEC 61010 EMC/EMC standards. Ability to generate and review electrical schematics.
- 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.
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