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Staff Engineer

External
Exact Sciences logoExact Sciences · - CA - Redwood City
Full-timeOn-site1w ago
ComplianceData AnalysisLeadershipMentoring
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Benefits

Vision insurance

Additional Information

Help us change lives At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others. Position Overview This role joins the Process Development & Automation (PDA) team on-site at the Redwood City clinical laboratory facility. PDA explores new automation and clinical tests, develops them to suit internal customer needs, then validates and implements the improvements for the laboratories we support. We focus on liquid handlers, high throughput, integrated workcells performing nucleic acid extraction and qPCR analysis. The team also validates automated HistoPathology equipment and processes that include Software as a Service (SaaS) integration with Laboratory Information Systems (LIS). The role reports to the Validation function that is responsible test design, protocol and report writing, coordinating test execution with the laboratories and IT, qualifying consumables and labware, and computer and software qualification for laboratory instruments. This Staff Engineer fills a unique gap between IT systems and laboratory functions, so the ideal candidate will have experience and exposure to process workflows both upstream and downstream of LIS integration interfaces. The job functions will include: Collaborate with end users and LIS developers to address needed improvements to current modules, design requirements for new test systems, validation, and implementation of the changes. Collaborate cross-functionally with internal and external partners to enhance existing workflows and develop new automated workflows in a complex, rapidly evolving clinical laboratory. Lead user acceptance testing (UAT) of new and changes to Laboratory IT systems, including validation of Laboratory Information System (LIS) system changes and upgrades. Coordinates, manages, implements, and provides technical engineering support for a variety of automation, IT, and software applications, and instruments used in the clinical laboratory. Essential Duties Include, but are not limited to, the following: Leads User Acceptance Testing (UAT) including IT systems preparation, sample coordination, test case generation/review, and document preparation for quality / regulatory compliance. Learn existing and new laboratory process flows to be an effective advocate of end user requirements. Leads planning activities and conducts complex platform eligibility testing, systems integration, or performance testing. Hold regular meetings, assign tasks, enforce accountability to timelines, and ensure deliverables are met. Work with project managers and cross-functional teams on user requirements, factory acceptance tests, validation planning, site acceptance tests, pre-installation planning, initial installation, setup, maintenance, and improvement for new or upgraded instrumentation and automation systems. Able to influence others and gain acceptance and build consensus. Ability to apply project leadership skills in planning, delegating, influencing, and managing priorities. Ability to manage moderately complex projects and initiatives, typically within one platform or business organization. Accurately estimates task effort, including work by others. Defines and modifies protocols and procedures; conducts complex testing activities and data analysis. Applies technical knowledge to company products and to recommend product enhancements. Able to troubleshoot complex issues Laboratory anomalies. Contributes ideas and insights to new technologies, testing methodologies, applications, techniques, or procedures that are creative and practical. Provides input for project design & development. Develops process architectures and functional specifications based on user and workflow requirements. Makes decisions that involve the consideration of complex issues. Works autonomously and checks-in with supervisor/project lead as decisions are made. Responds to change with flexibility and adapts quickly. Discusses and presents factual information to other members of the same organization; Ability to convey very complex information in both written and oral form. Actively and constructively contributes to other's designs through design reviews within same organization. Facilitates reuse by communicating available technologies and opportunities within the organization. Provide mentoring and technical guidance to service engineers, laboratory technicians, and other members of the Process Development and Automation team. Beginning to demonstrate leadership behaviors: humility, will, best team and vision. Demonstrates understanding of company's internal and external customer needs and how they affect business unit products and services. Brings company and industry knowledge as well as cre


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