The Mission of the Precision Oncology Business Unit of Exact Sciences 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 Device and Process 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 Device and Process Systems Engineer will lead projects to innovate, 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 Lab Operations, the successful candidate will also be a key member on project teams developing new IVD devices and laboratory automations, ensuring their efficient and effective transfer into production, and will also contribute to ongoing improvements of existing commercialized processes and products.
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.
Essential Duties and Responsibilities
Participate in or lead cross-functional process development teams to innovate, plan, develop, validate, and implement robust and scalable laboratory and business processes.
Participate in new product development programs, operationalizing production processes including manufacturing, product distribution, and order to revenue workflows.
Collaborate with internal Manufacturing, Supply Chain, R&D, and QA teams, and with third party technology partners, contract IVD manufacturers and logistics partners as needed to create, scale, and validate supply chain, manufacturing, and distribution processes and infrastructure.
Translate business needs and customer requirements 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.
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.
Ability to assist and mentor junior Systems Engineer members.
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 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.
Deal with ambiguity and deliver simple engineering solutions to complex problems.
Apply understanding of complex end-user applications, collecting and clearly documenting user needs.
Ability to methodically break down complex applications into simpler elemental constituents and formulate clear and concise requirements to meet end user needs.
Perform work with minimal direction, exercising sound judgement in defining technical objectives of assignments.
Apply critical thinking skills to judiciously plan and prioritize project activities for maximum leverage and impact.
Apply leadership skills to align colleagues and partners around a vision, a plan to achieve it, and the execution of this plan.
Exhibit commitment to quality in the development, testing, and implementation of systems and processes to be used in diagnostic tests.
Ability to integrate and apply feedback in a professional manner.
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
Support and comply with the company’s Quality Management System policies and procedures.
Regular and reliable attendance.
Ability to work designated schedule.
Ability to work nights and/or weekends, as needed.
Use of computer, and or telephone for long periods of time may be necessary.
Considerable periods of time may be spent concentrating and or analyzing data.
Some lifting (greater than 25 pounds) may be necessary.
May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
Ability and means to travel between Red Wood City locations.
Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
Qualifications
Minimum Qualifications
Bachelor’s degree in Engineering or related field; or High School Degree/General Education Diploma and 4 years of relevant experience in lieu of Bachelor’s degree.
10 + years of IVD, laboratory automation, and/or medical device experience.
Proficient familiarity with the principles and tools for Innovation Processes (i.e., TRIZ), Lean Design, Robust Design, Design for Six Sigma, Systems Engineering, DOE, VOC, and Design for Reliability, and related methodologies.
Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
Authorization to work in the United States without sponsorship.
Preferred Qualifications
Advanced Engineering degree.
Experience with development of business workflows using enterprise software systems for clinical diagnostic applications.
Experience in developing diagnostic test in a highly regulated environment (i.e., CLIA, FDA, ISO13485 etc.).
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.