About the Role:

Hound Labs seeks an experienced Systems Engineer to play a critical role on our team as we create leading edge diagnostic systems and applications.  The Lead Systems Engineer will work with our external development partners while simultaneously building our internal engineering capabilities.  The successful candidate will combine extensive experience with the development and qualification of medical devices or IVD systems with a deep technical background in the definition, integration, and characterization of hardware, software, and chemical systems.

The Specific Duties and Responsibilities Include:

·       Identify concepts, architectural solutions, and system designs to meet program needs while balancing technical, schedule, and cost constraints

·       Develop design concepts or models, oversee prototype construction, and conduct performance testing to determine practical feasibility of concepts

·       Lead and participate in reviews of design inputs and outputs

·       Develop and execute system integration strategy, including execution of system characterization and performance evaluation

·       Act as technical lead for development of system and subsystem requirements and design specifications

·       Identify and propose mitigations for technical issues

·       Plan and manage system and subsystem verification activities

·       Develop and analyze error budget models

·       Develop and analyze interface specifications

·       Perform risk management according to ISO 14971

·       Contribute to development and support of FDA compliant development processes

Basic Qualifications:

·       Bachelor’s Degree in an engineering discipline

·       8 Years professional experience developing IVD or medical device products

·       Excellent communication skills

·       Proficiency with relevant systems engineering methods (requirements creation & management, design control, risk management according to ISO 14971, verification & validation)

·       Project leadership skills

·       Experience in implementing and using automated systems engineering tools

Preferred Qualifications:

·       Advanced degree in a relevant engineering discipline

·       Experience in one or more of the following technical domains:  optics, fluidics/microfluidics, embedded systems, mechanical design, diagnostic assay development

·       Experience with human factors assessment

·       Team leadership experience

Primary Work Location:  Newark, CA, with occasional travel to Hound Labs HQ in Oakland, CA

About Hound Labs:

Hound Labs is a technology startup that has created an ultra-sensitive breath analysis technology platform. We are applying our technology to solve fundamental issues with disease and drug detection. The first application of our technology, the Hound Alcohol and Marijuana Breathalyzer, solves the public safety problem associated with marijuana legalization: how to objectively determine if someone has recently consumed marijuana. Founded in 2014, Hound Labs is backed by Benchmark Capital, Icon Ventures, and prominent individual investors.