Chronus Health, a medical diagnostic start-up, is on a mission is to build a revolutionary diagnostic point of care platform that accelerates patient care at a dramatically lower cost 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.

We are looking for an energetic and experienced individual to join our research and development team. The primary function of this role is to lead the Hardware and System Engineering group. This position will also manage and build the scientific and engineering team focused on developing the IVD instrument and disposable test cartridges using microfluidic and microfabrication technologies. In this leadership role, you will guide our critical engineering teams to build our next-generation microfluidics platform. This individual will report directly to the CTO and be an integral part of building a fast-growing team and driving the platform execution. If you believe in pushing the boundaries and changing the status quo to impact the healthcare industry significantly, we would love to hear from you.

Responsibilities

• Lead a multidisciplinary team of engineers in electrical engineering, mechanical engineering, material scientists, firmware development, consumable, and sensor subsystem development
• Provide leadership for the definition of the system architecture, design, interfaces, risks & tradeoffs to support product development schedules
• Coordinate with the leadership team to realize the product vision and strategic initiatives consistent with Chronus Health’s strategy and goals
• Lead all aspects of the vision, strategy, roadmap, and lifecycle management of the system and consumable cartridge/sensor development in collaboration with the leadership team
• Work closely with the bioassay development, software, data sciences, quality, and manufacturing team leads to ensure product requirements and successfully execute projects
• Responsible for supporting and enabling hardware and testing automation
• Responsible for ensuring compliance of internal and external tools per regulations applicable to medical devices and clinical research
• Responsible for leading initiatives and building team-focused development of the system and disposal cartridge in collaboration with external vendors
• Collaborate with cross-functional teams on feature specifications, collect requirements from all relevant partners, and make decisions about implementation and resource trade-offs
• Ensure that product releases successfully meet user needs and that key performance indicators for product performance are defined and met
• Coordinate with external vendors and the internal team to drive the hardware platform development
• Provide technical leadership, mentorship, and coaching to team members
• Participate in the management of internal timelines and budgets
• Participate in the preparation of technical documents for FDA submissions
• Communicate project status to escalate issues to high-level management, users, and staff
• Provide staff development opportunities based on associate and business needs
• Participate in hiring/disciplinary decisions affecting employees and contractors

Requirements

• 10+ years of industry experience with a Bachelors’ in Electrical Engineering, Biomedical Engineering, or related field. M.S or Ph.D. with industry experience in medical devices or healthcare products, specifically the development of IVD products or hematology products is preferred
• 5+ years of management and leadership experience
• 5+ years designing and developing hardware systems in regulated environments
• 5+ Experience developing IVD diagnostic products and a solid understanding of design control requirements (21CFR820, ISO14971). Development experience in cartridge-based consumable IVD products is preferred
• Experience in characterizing and verifying systems and manufacturing processes, including hardware, software, and reagent elements in systems
• Solid technical background in high complexity systems, e.g., flows cytometer assays, CBC systems, Chemistry analyzers, etc.
• Experience developing one or more product(s) that incorporate artificial intelligence and machine learning algorithms is a plus
• Meticulous attention to detail, proficient reasoning, and problem-solving skills in experimental design, data analysis, and interpretation
• Strong technical background in designing and writing essential development study documents, including study protocols, experimental records, and study reports, etc.
• Knowledge of laboratory automation, system software, and statistics is essential
• Seek opportunities to improve efficiency and increase capacity for the business
• Strong interpersonal skills with the ability to communicate effectively