The Instrument Hardware Engineering Project Lead will be a key architect for Cytovale’s next generation instrumentation. They will work closely with other Product Development Engineers (Software, Electrical, and Systems) to improve product hardware architecture and 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.

Responsibilities

• Define and direct hardware architecture for the next generation Cytovale System.
• Selectively apply architectural improvements to the Generation 1 IntelliSep 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.
• Interface directly with design partners and contract manufacturers to facilitate effective completion of engineering activities.
• Maintain project plans, budgets, and sprint plans throughout the development process.
• Brainstorm and prototype concepts to improve upon current system performance and generate intellectual property.
• 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.
• 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 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 projects with 5+ contributors, including external consultants.
• 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.
• 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: 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.

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.

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.
• 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.