Director Of Systems Integrations (Microfluidics Engineering)

Director of Systems Integration (Microfluidics Engineering)

LexaGene is developing an automated instrument for rapid pathogen detection in human clinical diagnostics, veterinary diagnostics, food safety, and other markets. Join our team as we ramp up for the commercial build of our flagship MiQLab system, which can quickly detect, at point-of-need, novel infectious diseases like COVID-19 and prevent the spread of future outbreaks.

An exciting opportunity exists for a Director of Systems Integration (Microfluidics Engineering).

Essential Job Responsibilities:

• Manages R&D core team activities related to assay optimization, fluidics development, assay system integration, troubleshooting and failure analysis throughout product commercialization.

• Applies system engineering principles to develop cost-effective, reliable, high-quality systems that satisfy customer needs and drive business strategies.

• Supports the optimization of sample preparation, real time PCR and RT-PCR assays on LexaGene’s MiQLab systems during the development of complex in vitro diagnostic tests.

• Identifies robust system architectures that are scalable, manufacturable, and serviceable.

• Develops sub-systems for micro-fluidic processing and imaging based on fundamental physics, physical models, and related design approaches.

• Applies sophisticated analytical problem solving skills to reagent and system integration issues to identify critical performance factors for assay development.

• Collaborates cross-functionally with Biology, Operations, Software, Marketing and other functions to a deliver point-of-care, sample-to-answer platform that meet the needs of LexaGene’s product portfolio.

• Leads a cross functional team comprising junior and senior engineers from diverse skill sets (Mechanical, Electrical, Optical, Firmware) to design, test, and validate a new highly spatially multiplexed instrumentation platform, ensuring performance and compatibility with assay products.

• Coordinates with Technical Leads and Project Management to prioritize activities and manage schedules and resources to drive projects to successful on-time completion of Design Verification Activities.

• Hands-on design and execution of complex test methods to assess hardware and system performance per Design Input Requirements.

• Ensures compliance with quality and regulatory requirements by applying design control processes such as risk management, configuration management, requirements management and verification testing.

• Manages the innovation of new technologies, algorithms, and methods necessary to advance LexaGene technology into new markets.

• Maintains internal knowledge base of LexaGene product hardware, software, consumable, reagent, and fluidic design and performance history as well as cross-functional implementation of design rules.

MINIMUM REQUIREMENTS:

Education or Experience (in years):

Bachelor’s degree with 12+ years of related work experience OR Master’s degree with 10+ years of related work experience in IVD commercialization.

Bachelor’s degree or equivalent in a relevant field such as Biology, Biochemistry, Bioengineering, Biomedical Engineering, etc. Previous experience as a hands-on engineer, scientist, or product developer (e.g. System Integration Engineer, System Development Engineer, or related occupation).

Advanced degree with practical hands-on experience may substitute for years of industry experience.

Knowledge and skills:

• Strong leadership skills, Microfluidics expertise.
• Medical device and/or in vitro Diagnostic product launch experience.
• Experience with developing and integrating complex instrumentation systems which incorporate optical, mechanical, thermal, and firmware components.
• Knowledge of a broad range of principles of biology, chemistry, physics, and thermodynamics.
• Must have strong integration analytical and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system interoperability problems.
• Working knowledge of design of experiments, interpretation of test results, failure investigation and root cause failure analysis.
• Excellent communication skills. Must be able to communicate verbally in an efficient and effective manner and be proficient in written documentation and technical presentations. Must be effective at communication with all levels of employees.
• Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies and tasks.
• Demonstrated leadership skills including organization and prioritization of complex activities, comfort and effectiveness in providing technical direction to others, and quantitative delivery of team objectives.

Applicants should expect a rapid-growth environment, where there is room for career advancement for talented and driven employees. Industry competitive benefits are offered, including health, dental, vision, 401k, and more.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Work Remotely:

• No