This Senior Process Engineer will ensure the use of engineering best practices and operational excellence methodologies in the design, implementation, and ongoing improvement of our laboratory and business processes. He or she will participate in or lead cross-functional process design and reengineering projects to maximize efficiency, quality, scalability, and cost of the processes used commercially in Genomic Health's Clinical Laboratory to provide results from our unique Oncotype DX diagnostic tests to cancer patients. These efforts will include stand-alone projects designed to improve operational performance with existing technology and infrastructure as well as projects designed to maximize leverage from the introduction of new enterprise software systems (e.g. LIMS, CRM, and ERP), high-throughput robotics and other instrumentation for our sophisticated genomic assays.
The workflow analysis and engineering projects addressed by this Senior Process Engineer will span a range of functional areas and workflows associated with our commercial patient sample testing process, including accessioning of received patient specimens, sample preparation in Histology, review of each sample by our Pathology team, genomic analysis, and reporting of results. The scope of this position also includes design and continual improvement of related Genomic Health operational processes (e.g. in Customer Service, Manufacturing, Quality Control, and Inventory Management) and processes used in R&D for large-scale clinical development studies. This Senior Process Engineer will apply appropriate operational excellence methodologies (e.g. Lean Six Sigma, TOC principles) and a holistic perspective to these projects, understanding the interrelationships between these processes in the context of our overall business objectives.
Working within interdisciplinary project teams, the successful candidate will clearly document the business need driving the project, and translate these business requirements effectively into well-documented functional requirements describing how the newly designed process will meet this need. He or she will lead the observation, measurement, and mapping of current ("as-is") processes and the analysis of their actual vs. desired operational performance characteristics.
The successful candidate will systematically evaluate proposed solutions and the risks, benefits, and tradeoffs associated with each. He or she will collaborate effectively with other project team members representing internal customers, subject matter experts, and solution providers in Process Engineering, Information Technology, R&D, Biostatistics, and other functional areas on these workflow analysis and design efforts, ensuring that the risks, benefits, and tradeoffs associated with each proposed design solution are systematically evaluated and well understood. He or she will participate in or lead the appropriate cross-functional team in the detailed design and implementation of these new processes, ensuring that timelines, key milestones, and project dependencies are clearly defined and communicated.
- Identify and quantify opportunities for improvement of key operational capabilities and performance through design of improved laboratory and business processes
- Collect and document fundamental (solution-agnostic) business requirements relevant to specific laboratory and/or business process design or re-engineering projects
- Facilitate the definition of key performance indicators for individual processes by the appropriate business process owners, and - document these measures of process efficiency, effectiveness, cost, throughput, scalability, extensibility, labor requirements, and other relevant aspects
- Create "as-is" process maps for existing laboratory and business processes to document actual practice, also measuring and documenting the performance of these processes with respect to key performance indicators, based on direct observation and collaboration with process owners, practitioners, and subject matter experts
- Apply engineering and operational excellence best practices to lead cross functional teams in the design of re-engineered processes which leverage the best available technologies (robotics, software systems, etc.), maximizing performance relative to key performance indicators
- Document new proposed process designs including high-level descriptions, "to-be" process maps, and the risks, benefits, and tradeoffs associated with these proposed designs
- Organize and present process design options to the appropriate decision-making bodies with the context required to enable high quality decision making
- Lead cross-functional teams in the detailed design of these new processes, including development and implementation planning, construction of project milestones, timelines, and resource requirements, dependencies, risks and mitigations, costs, etc.
- Provide leadership for continuous process improvement across a spectrum of laboratory and business processes, making appropriate use of operational excellence methodologies
- Mentor and guide GHI employees in multiple functional areas the effective use operational excellence methodologies
- Other duties as assigned.
- At least 8 years of relevant experience in the design, implementation, and continuous improvement of scalable, high complexity manufacturing or sample processing workflows is required
- A B.S. or higher degree in a relevant engineering or scientific discipline is required
- Experience and expertise in the collection and documentation of business requirements and the functional engineering requirements for proposed workflow design solutions
- Exceptional written and verbal communication skills, and the ability to communicate and collaborate effectively across technical disciplines, organizational boundaries, and levels within the organization are essential
- Able to integrate and apply feedback in a professional manner
- Able to prioritize and drive to results with a high emphasis on quality
- Ability to work as part of a team
- Experience with the design and implementation of process automation for robustness and throughput is highly desirable
- A track record of successful leadership in the effective use of operational excellence methodologies (e.g. Lean Six Sigma, TOC) to achieve significant business results is highly desirable
- Experience with development and delivery of clinical diagnostics (including high-complexity laboratory developed tests, in vitro diagnostic products, or medical devices) and the associated regulatory frameworks is highly desirable
- Strong working knowledge of Histology and Pathology workflows for solid tumor tissue are highly desirable
Familiarity with standard molecular biology techniques such as nucleic acid isolation, RNA/DNA quantification, PCR and RT-PCR, and DNA sequencing is highly desirable
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:
Select or Delete Below as Appropriate:
- Travel Requirements: No Travel
- Standing or sitting for long periods of time may be necessary
- Some lifting (greater than 25 pounds) may be necessary; Facilities, Materials and Engineering employees occasionally must lift at least 50-75 pounds.
- May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high speed centrifugation
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