Senior Systems Engineer – Cartridge Architecture
Summary:
The Senior Systems Engineer – Cartridge Architecture will be responsible for providing leadership to cross-functional teams to develop industry-leading DNA sequencing cartridges and consumables for clinical applications in an exciting, fast-paced environment. The foundation of all activities for this role is a broad, solid grasp of multiple areas of engineering, physics and molecular biology, and the ability to climb new learning curves quickly. Primary responsibilities include development of system models/budgets, contributing to system & sub-system architecture decisions, managing specifications and requirements, and developing test strategies for critical parameter understanding and verification. A successful candidate will possess strong organizational and communication skills to facilitate successful product development across consumables, hardware, firmware, software, and chemistry teams.
Job Activities:
- Significantly contribute to developing new architectures for high volume medical device consumables that integrate microfluidics, chemistry, and imaging
- Develop system models that guide design decisions. These can include system tolerance budgets, runtime models, SNR models, performance models, COGS models, etc. Provide mentorship to sub-system engineers in the development of models that guide lower-level design decisions.
- Support architecture definition by working across sub-system design teams to align overlapping design requirements /constraints and drive teams in developing concepts, evaluating risks, and efficiently concluding on a design path.
- Lead teams through complex root-cause analysis in which there are many possible root causes that involve various areas of physics. Mentor others on systematic best practices for problem solving (8D method, fish-bone diagrams, etc.).
- Build the information foundation for successful architecture activity. Create and maintain system requirements, specifications, and functional workflows. Examples include biochemistry workflows, hardware timing diagrams, and assembly process workflows.
- Develop, manage, execute test strategies for Critical Parameter Management which identify the sensitivities and acceptable operating ranges for input parameters relative to output metrics. Leverage Design of Experiments for efficient coverage of complex parameter space.
- Own the seams between teams, especially including the definition and documentation of interfaces between consumables, chemistry, hardware, firmware, and software. Culture the ecosystem mindset in practice.
Required Skills & Experience:
- Engineering, Physics, Biophysics, or related master’s degree with 5+ years of experience or Ph.D. with 0 -3 years of experience in consumables, instrumentation, or product development.
- highly motivated to work cross-functionally in the ecosystem of fluidics, liquid handling, precision motion, and biochemistry
- Strong analytical background, with record of using system models to drive decisions.
- Demonstrated track record of rapidly climbing steep learning curves. Enthusiasm for tackling tough problems on an aggressive schedule.
- Experience with definition, setup, characterization, and testing of complex systems, including design of experiments, reliability life tests, and root cause analysis.
- Experience and fluency in scientific computing and simulation, such as Python, MATLAB, or R
- Effective communication and presentation skills (ability to distill complex technical information into product decisions and business recommendations).
Preferred Skills & Experience:
- Technically proficient in disciplines of integrated devices or cartridges including plastics design & injection molding, microfluidics, heat transfer, surface chemistry, biochemistry interactions, and thermal cycling.
- Experience in consumables design and development
- Technically proficient in disciplines including optics, microfluidics, heat transfer, precision motion, and electronics.
- Experience with specification and requirement management (JAMA), design traceability, design verification and validation.
- Experience in process engineering methodologies such as FMEA (Failure Mode and Effects Analysis), SPC, Gauge R&R, Critical Parameter Management, and Design for Manufacturability to measure and improve process capability and robustness
- Fluency in the methods and vocabulary of nucleic acid analytical techniques, genetic sequencing, and molecular biology.
- Experience with Signal-to-noise Ratio (SNR) modeling
- Experience developing products in a regulated environment (FDA 510k approval process)
- Understanding of the physics of failure approach to reliability, failure mechanisms, failure analysis techniques, and basic probability concepts.