Essential Job Responsibilities:
MINIMUM REQUIREMENTS: Education or Experience (in years):
- Supports Bio R&D core team activities related to assay optimization, fluidics development, assay system integration, and troubleshooting and failure analysis.
- Supports the optimization of sample preparation, real time PCR and RT-PCR assays on Cepheid GeneXpert Systems during the development of complex in vitro diagnostic tests.
- 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 R&D, Consumables R&D, Software, Technical Support, Service, and other functions to deliver a system-level instrumentation platform that meets the needs of Cepheid's Molecular Diagnostics and Oncology 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.
- Develops analysis algorithms necessary for efficient and intuitive handling of large combinatoric data sets and works with Software Engineering to implement and test.
- Innovates new technologies, algorithms, and methods necessary to advance Cepheid technology into new market areas such as oncology and genetics.
- Maintains internal knowledge base of GeneXpert product hardware, software, consumable, reagent, and fluidic design and performance history as well as cross-functionalimplementation of design rules.
Knowledge and skills:
- Bachelor's degree with 12+ years of related work experience OR Master's degree with 10+ years of related work experience OR Doctoral degree with 8+ years related work experience.
- Bachelor's degreeor equivalent in a relevant field such as Biology, Biochemistry, Bioengineering, Biomedical Engineering, etc.
- Previous experience as a hands-onengineer, scientist, or product developer(e.g. System Integration Engineer, System DevelopmentEngineer, or related occupation).
- Advanced degree with practical hands-on experience may substitute for years of industry experience.
PREFERRED REQUIREMENTS (optional):
- Strong leadership skills and emotional intelligence.
- Experience with developing and integrating complex instrumentation systems which incorporate optical, mechanical, thermal, and firmwarecomponents.
- Data analysis expertise and experience with various data analysis software packages such as Origin, Matlab, Mathematica, Minitab or other.
- Well-developedmathematical and statistical analysis skills.
- Knowledge of a broad range of principles of biology, chemistry and physics, such as spectroscopic techniques, organic chemistry, electromagnetic theory, 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.
- Programming experience in C/C++, Python, or other.
- Microfluidics expertise.
- Medical device and/or in vitro Diagnostic product launch experience.
- Understanding of assay product development lifecycle.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here .