Truvian is advancing health through convenient, affordable, and actionable blood testing. Our compact, automated system rapidly produces lab-accurate results for a full suite of tests from a small sample of blood, giving individuals unprecedented access to information that shapes their health. This position is for a highly motivated senior-level engineer with a strong background of System engineering. This position requires strong technical and communication skills to support the design and development of a new IVD blood analyzer. The Senior Systems Engineer will work as a member of the product development team in the conception, design, development, testing and integration of

electro-mechanical, thermal and optical sub-systems into the Truvian product family. This individual will apply best engineering practices to solve complex problems. The engineer is expected to be able to complete assigned projects with minimal supervision.

Responsibilities:

• Work with assay development, software, engineering, and manufacturing teams, ensuring well-designed and executed experiments toward fully integrated functionality of a multi-modal benchtop IVD instrument
• Troubleshoot issues and suggest creative solutions to system-level issues
• Manage continuous change, release & configuration management of the system, and its sub-systems and interfaces
• Lead cross-functional teams to perform root cause analysis of issues, improve reliability and/or enhance performance of diagnostic systems at various stages of development
• Lead/contribute to cross functional teams in developing strategies for system level product integration and testing; including software, electrical, and mechanical aspects of the system
• Aid in the development of the system level timing architecture for the IVD platform
• Analyze large complex data sets utilizing broad experience and knowledge
• Innovate new approaches and methods necessary to advance progress
• Develop verification and validation test plans; lead and/or execute study protocols with associated auditable documentation
• Drive risk analyses and FMEA activities with project team, refine requirements and improve designs, lead integration and testing activities
• Develop system error budgets and conduct gage repeatability and reproducibility analyses

Qualifications and Skills:

• Bachelor’s Degree in mechanical, electrical, biomedical engineering or equivalent with 8+ years of IVD experience or an MS degree in mechanical, electrical or biomedical engineering, or equivalent with 6+ years of IVD experience
• Prior experience in medical device or IVD product development required
• Experience in working on complex systems (fluidic, mechanical, and optical)
• Proficient in communicating complex technical situations in an understandable way
• Experience in delivering a product from research to market
• Strong background in product design and development
• Strong understanding of the fundamentals of design controls
• Proficient with Solidworks and other CAD software
• Very strong analytical and problem-solving skills; organized and efficient
• Proven interpersonal, communication, and presentation skills; excellent time management skills
• Able to excel in collaborative, fast-paced, and evolving start up environment; able to manage competing priorities
• Knowledge of electrical systems including motors, pumps, sensors, embedded system design, firmware is highly desired