Chronus Health, a medical diagnostic company, is on a mission to build a global point-of-care platform for all standard blood tests. We are a company-in-residence at Fogarty Innovation, based on the campus of El Camino Hospital in Mountain View, California.

Chronus Health is a fast-paced start-up expanding its biotech and engineering team. This is a unique opportunity to be part of the core team and build the product from the ground up. If you believe in pushing the boundaries and changing the status quo to impact on the healthcare industry, we'd love to hear from you! **
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Responsibilities

• Provides technical knowledge of system engineering principles and their application to develop cost-effective, reliable, and high-quality systems that satisfy customer needs and business requirements

• Reviews and analyzes customer requirements and articulates and derives system requirements and functions

• Generates and analyzes alternative architectures, developing preferred system architectures, communicating, and coordinating with cross-functional development teams, and assisting with the management of the balance between development cost, schedule, quality, and performance

• Participates and/or leads cross-functional teams in efforts relating to system requirements definition, system functional decomposition, system architecture definition, system modeling, and requirements traceability

• Leads/performs testing (characterization, verification, integration, and validation) of the system & sub-system components including plans, protocols, and reports

• Conducts and participates in design/project technical reviews

• Leads FMEA (Failure Modes and Effects Analysis) as a tool to drive quality and manage risk

Qualifications

• 7+ years of experience in the development of electromechanical medical devices

• BS in Engineering. MS desirable

• Understanding of QSR/ISO regulations & standards, risk management (ISO14971)

• Understanding of bioassays development process and technical challenges

• Fundamental understanding of statistics and data analysis

• Strong interpersonal skills with the ability to communicate effectively

• Strong attention to detail with excellent time management and organizational skills

• Prior experience in developing urinalysis, hematology, clinical chemistry, immunoassay, and other IVD instrumentation in an FDA-regulated environment – highly desired

• Hands-on experience with sample preparation, fluidic handling, control systems, microfluidics, and microfabrication – desired