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Senior Systems Engineer

Apply Share Job ID 806 Category Engineering Job Location Redwood City, California Posted Date 05/26/2018

Overview:

POSITION SUMMARY:
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. You will apply your excellent engineering knowledge and quick decision making to simplify and solve challenging problems quickly. 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.


RESPONSIBILITIES:
-Genomic Health's Mission is to transform treatment decisions and outcomes in cancer by delivering clinically actionable diagnostics, both as in-vitro diagnostic (IVD) devices and as Laboratory Developed Tests (LDTs) conducted in our Redwood City Clinical Laboratory. Reporting to the Director of Systems Engineering, the Senior Systems Engineer will
provide technical expertise, vision and leadership to drive continuous improvement of our state-of-the-art diagnostic tests for cancer patients.

The Senior Systems Engineer will lead projects to analyze, design, and implement improved business processes and laboratory workflows for diagnostic tests conducted in our Clinical Laboratory. Beginning with analysis of the business process requirements, these process design and integration efforts will encompass the generation and collection of requirements, design and architecture, incorporation of applicable automation technologies, integration of multiple subsystems, and end-to-end testing.

Representing Operations, the successful candidate will also be a key member on project teams developing new best-in-class IVD devices, ensuring their efficient and effective transfer into production, and will also contribute to ongoing improvements of existing commercialized processes and products. In this role, the Senior Systems Engineer will lead the design and implementation of the business processes by which the new IVD product or LDT test is ordered and paid for (leveraging Genomic Health's enterprise software systems), in addition to ensuring implementation of appropriately robust manufacturing and supply chain infrastructure.

It is critical that the candidate has strong expertise in medical device quality standards and regulations, including ISO13485, ISO14971, 21CFR Part 820, and experience in the operationalization of new diagnostic and/or medical devices. Demonstrated ability to effectively execute multiple projects simultaneously with Lean Methodology is required. Experience with business process analysis and design is required, ideally including experience with order to revenue processes.

RESPONSIBILITIES:

- Participate in or lead cross-functional process improvement teams to plan, develop, validate, and implement robust and scalable laboratory and business processes required by Genomic Health's growing portfolio of LDT services and IVD products
- Participate in new product development programs, operationalizing production processes including manufacturing, product distribution, order to revenue workflows, and others for new LDT services and IVD products
- Collaborate with internal Manufacturing, Supply Chain, R&D, and QA teams, and with 3rd party contract IVD manufacturers and logistics partners as needed to create, scale, and validate supply chain, manufacturing, and distribution processes and infrastructure.
- Translate business needs into clear, well-vetted requirements, and conduct and guide requirement tracing, architecture design and other key Systems Engineering methodologies for new production processes
- Incorporate business strategy into project scope, plan and design that may involve multiple phased releases of the product or process
- Provide leadership in incorporating risk management into project planning and execution, conducting, facilitating, and reviewing risk assessments required in development and revision of production processes
- Systemize learning and best practices into practical procedures
- Function as Project Manager when leading projects using a robust development process including clear definition of deliverables, building and tracking development schedules, clearly defining project roles and responsibilities, managing stakeholder communication, and other best practices
- Manage engagements with outside partners, as required, to incorporate solutions into Genomic Health business workflows
- Advise and present options, recommendations, and plans, and status to senior management on projects and associated issues and risks
- Apply Robust Design / Design for Six Sigma principles to development of production processes
- Lead complex problem solving in design and support of production processes and associated processing equipment
- Provide expertise and leadership in Design of Experiments (DOE), failure analysis, root cause analysis, and associated statistical methods
- Other duties as assigned.


REQUIRED QUALIFICATIONS:

- A bachelor degree in engineering and at least 8 years of IVD and/or medical device experience
- Demonstrated ability to effectively lead and participate in multidisciplinary project teams, providing technical leadership and guidance to team members
- 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
- Successful track record in the application of project management best practices
- Ability to deal with ambiguity, and a successful track record in delivering simple engineering solutions to complex problems
- Familiarity with the principles and tools for Lean Design, Robust Design, Design for Six Sigma, DOE, and Design for Reliability and related methodologies
- 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
- Experience methodically breaking down complex applications into simpler elemental constituents and formulating clear and concise requirements to meet end user needs
- Demonstrated ability to perform work with minimal direction, exercising sound judgement in defining technical objectives of assignments- 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, a plan to achieve it, and the execution of this plan
- Strong commitment to quality in the development, testing, and implementation of systems and processes to be used in Genomic Health's diagnostic tests
- Ability to integrate and apply feedback in a professional manner


DESIRED QUALIFICATIONS:

- Advanced engineering degree
- Experience with development of business workflows using enterprise software systems for clinical diagnostic applications
- Experience with requirements management tools (Jama, Aligned, DOORS, etc.)

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As the Senior Systems 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 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.
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If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!