Working with and reporting to the Director of Systems Engineering, you as the Senior Systems Engineer, 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 or as IVD devices. These efforts will include the design and implementation of diagnostic tests and IVD devices from early design through transfer to Operations and scale-up, and ongoing improvements of existing commercialized processes and products. You will be responsible for leading multi-functional development teams with members from many different disciplines including external partners and collaborators to deliver the optimal products and solutions.
- 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.
- Demonstrated expertise with hands-on experience in translating needs to clearly
well-vetted requirements, requirement tracing, architecture design and other key
systems Engineering methodologies.
- Incorporate business strategy into project scope, plan and design that may
involve multiple phased releases of the product.
- 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 projects and associated issues and risks.
- Apply Robust Design / Design for Six Sigma principles to the development.
- Lead complex problem solving in product design and our automated process
equipment. Authority on Design of Experiments (DOE), failure analysis and root -
cause analysis with a strong background in statistics.
- Other duties as assigned.