| Reporting to the Director of Process Development within Operations, the Process and Development Technical Lead will provide expertise, vision, and leadership in process design and development to optimize process flow, increase consistency, improve operating sustainability and scalability, and safety of end-users. The Technical Lead will support internal development, scale-up, and ongoing improvements of existing commercialized diagnostic tests, starting with user and system requirement gathering and culminating in validation. Efforts will encompass the generation and collection of requirements, system design and architecture, integration of subsystems, and transfer of workflow processes to Operations. The successful candidate will provide expertise in engineering design, process development, design transfer, and scale-up, and assist in problem-solving with regards to equipment, software and other systems. He/she will participate in and lead cross-functional teams with members from many different disciplines and functional areas, including but not limited to, Engineering, Clinical Laboratory Operations, Supply Chain, Manufacturing, Biostatistics, Information Technology, Quality, R&D, and external partners and collaborators. In addition, he/she is expected to enter into this position with substantial manufacturing engineering experience and knowledge through hands-on industry experience. RESPONSIBILITIES / DUTIES: • Participate in and lead cross-functional teams in the strategic and tactical planning, developing, and implementing robust and scalable process engineering solutions and infrastructure for Genomic Health’s Laboratory Developed Tests (LDT).
• Incorporate business strategy into project scope, plan, and design that may involve multiple phased releases.
• Collect and document clear and complete requirements, e.g., user requirements, system requirements, risk assessments, trace matrices, FMEA, etc. These requirements are then translated into clearly documented, well-vetted requirements for the hardware and/or software systems as part of the engineering solutions.
• Work with Project Management to build and track progress using a robust development process.
• Advise and present options, recommendations, solutions, and executable plans to management on projects with the associated issues and risks.
• Mentor junior engineers by providing technical guidance and as-needed assistance on projects based upon his/her professional and technical experience.
• Provide leadership on best practices for the development of processes and products in a regulated environment.
• Apply Robust Design / Design for Six Sigma principles to the development of solutions.
• Serve as a subject matter expert on the engineering workflows, providing expertise in this area to colleagues outside of Engineering.
• When needed, manage engagements with outside partners as necessary to incorporate their laboratory tests into Genomic Health’s business workflows.
• Other duties as assigned. |
