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.
Required: · An engineering degree and at least 12 years of relevant engineering experience with complex workflows and/or products within the medical device, (bio)pharmaceutical environment, or applicable field. · Experience in the design, development, and implementation of solutions comprised of integrated automated and manual workflows including software components in a highly regulated environment (ISO 13485 or 21 CFR Part 820, or cGMP using 21 CFR Part 210, 21 CFR Part 211). · Track record of successfully leading projects holistically from inception to successful implementation with cross-functional participation in a matrixed environment. · Expert-level understanding and application of user requirements, system requirements, risk assessments, trace matrices, FMEA, etc. translating into a successful track record in understanding complex end-user applications, collecting and clearly documenting end-user needs, and translating those into clear, concise, and testable requirements. · Demonstrated experience in process optimization involving complex workflows comprising both system equipment and software components to ensure user and business requirements are met. · Superb written and oral communication skills and demonstrated excellence in collaborating with colleagues and customers from a wide variety of scientific, engineering, operational, and regulatory disciplines across the organization at many different levels. · Demonstrated ability to effectively lead and participate in cross-functional project teams. · Critical thinking skills, along with high attention to detail, required to plan and prioritize project activities for maximum leverage, impact, and return on investment. · Demonstrated leadership skills required to align colleagues and stakeholders around a vision and a plan to achieve it, and to execute this plan. · Strong and consistent commitment to quality. · Ability to integrate and apply feedback in a professional manner.
Internal Number: 1455
About Genomic Health, a subsidiary of Exact Sciences
Exact Sciences and Genomic Health have come together, taking earlier cancer detection and treatment insights and monitoring to the next level. By combining our portfolio of products, we are continuing our relentless pursuit of innovative solutions of earlier detection and smarter answers.