Senior Systems Engineer (Process & Device)

Genomic Health
Job Location
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Redwood City, CA 94404
Job Description

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.




- A bachelor degree in engineering and at least 8 years of relevant experience.

- 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.

- 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 the 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 multi-functional project

- 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.

- Strong and consistent commitment to quality in the development, testing, and
implementation of systems to be used in Genomic Health's laboratory developed

- Ability to integrate and apply feedback in a professional manner.

- Advanced engineering degree.

- Medical device development

- Experience with development of business workflows using enterprise software
systems for clinical diagnostic applications.

- Experience in developing diagnostic test in a highly-regulated environment (CLIA,
FDA, etc.)

- Experience in requirements management tools (Jama, Aligned, DOORS, etc.)

- Six Sigma Black Belt

- Experience in project management.

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