Reporting to the Director of Systems Engineering, as the Senior Systems Integration Engineer, you will provide technical expertise, vision and leadership in the development of industry-leading clinical diagnostic tests conducted within our state of the art Clinical Laboratory. These efforts will include the design and implementation of in-house diagnostic tests from early design through transfer to Operations and scale-up, integration of externally developed diagnostic tests, and ongoing improvements of existing commercialized diagnostic tests.
You will be responsible for leading cross-functional teams with members from many different disciplines including external partners and collaborators, to implement improved processes and equipment automation technology. These integration efforts will encompass the generation and collection of requirements, design and architecture, integration of subsystems, and testing of the entire workflow. You should feel confident in delivering creative problem solving with regards to automation equipment, software and other systems.
- Participate in or lead cross-functional teams planning, developing, validating, and implementing robust and scalable integration solutions from order to revenue, or any subset of these process steps for new laboratory developed tests or for platforms for multiple products.
- Incorporate business strategy into project scope, plan and design that may involve multiple phased releases of the product.
- Collect and document clear and complete business requirements for Genomic Health's workflows.
- Translate these business requirements to clearly documented, well-vetted requirements for the different software and hardware systems used to implement the solution.
- Systemize learning and best practices into practical procedures.
- Work with Project Management to build a development schedule and track progress using a robust development process.
- Manage engagements with outside partners as necessary to incorporate their laboratory tests into Genomic Health business workflows.
- Advice and present options, recommendations, and plans to senior management on integration projects and associated issues and risks.
- Apply Robust Design / Design for Six Sigma principles to the development of Genomic Health workflows.
- Serve as a subject matter expert on the business workflows within Genomic Health, providing expertise in this area to colleagues outside of Engineering.
- Other duties as assigned.
- Experience in the design, development, and validation of solutions comprised of integrated automated and manual workflows, and software components.
- A track record of success in understanding complex end-user applications, collecting and clearly documenting user needs. Ability to methodically break down the complex applications into simpler elemental constituents and formulating the clear and concise requirements to meet the needs.
- Can perform work without direction. Exercises considerable latitude in determining technical objectives of assignment. Will serve as a technical lead and provide guidance to lower level personnel.
- Superb written and oral communication skills, and demonstrated excellence in communicating and collaborating with colleagues, customers and external collaborators from a wide variety of scientific, engineering, operational, and regulatory disciplines at many different levels.
- Demonstrated ability to effectively lead and participate in cross-functional project teams
- Critical thinking skills required to judiciously plan and prioritize project activities for maximum leverage and impact.
- Demonstrated leadership skills required to align colleagues and partners around a vision and a plan to achieve it, and to execute this plan.
- Ability to apply scientific principles to development activities and problem solving. Familiarity with lean design tools, DOE, process development and validation, and design for reliability.
- Strong and consistent commitment to quality in the development, testing, and implementation of systems to be used in Genomic Health's laboratory developed tests.
- Ability to integrate and apply feedback in a professional manner.
- A bachelor degree in engineering and at least 12 years of relevant systems integration experience.
- Advanced engineering degree.
- Experience with development of business workflows using enterprise software systems for clinical diagnostic applications.
- Digital Pathology and scanner development experience.
- Experience in the development of laboratory diagnostic tests using automated liquid handlers, qRT-PCR or sequencing.
- Experience in developing diagnostic test in a highly-regulated environment (CLIA, FDA, etc.).
- Experience in project management.