Staff Engineer, Process Dev & Automation - LIS/LIMS

Position Overview

TheStaff Engineer, Process Development & Automationcoordinates, manages, implements, and provides technical engineering support for a variety ofautomation ,IT, andsoftware applications, andinstrumentsused in the clinical laboratory.This position works and collaborates cross-functionally with internal and external partners to enhance existing workflows and develop new automated workflows in a complex, rapidly evolving clinical laboratory.This role willbe responsible forleadinguser acceptance testing (UAT)ofnew and changes to Laboratory IT systems, includingvalidation of LaboratoryInformationSystem (LIS) system changes and upgrades.The Staff Engineerwill 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.The StaffEngineer responsibilities may include assisting Lab Service, Process Development and Automation, and Laboratory Operations teamsin the process of selectingautomation,ITsystem design, integration, commissioning, and project documentation. Once resources areidentified, this role can get a project off the ground andrunningwith minimal support from management. TheStaff Engineer, Process Development & Automationcan make new processes, systems, validationmethodsor projects successful.

Essential Duties

Include, but are not limited to, the following:

• LeadsUser Acceptance Testing (UAT)includingIT systemspreparation,sample coordination, test case generation/review, and documentpreparation for quality / regulatory compliance.
• Definesand modifiesprotocols and procedures; conductscomplextesting activities and data analysis.
• Applies technical knowledge to company products and to recommend product enhancements.
• Able to troubleshootcomplexissuesLaboratoryanomalies.

• Contributes ideas and insights tonew technologies, testing methodologies, applications, techniques, or procedures that are creative and practical.
• Provides input for project design& development.
• Accurately estimates task effort, including work by others.
• Develops process architectures and functional specifications based on user and workflow requirements.
• Leads planning activities and conducts complexplatform eligibility testing, systems integration, or performance testing.
• 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 andadaptsquickly.
• Discusses and presentsfactual informationto other members of the same organization; Ability to conveyvery complexinformation in both written and oral form.
• Actively and constructively contributes toother'sdesigns through design reviews withinsameorganization.
• Facilitates reuse by communicating available technologies and opportunities within the organization.
• Able to influence others and gain acceptance and build consensus.
• Ability to manage moderately complex projects and initiatives, typically within one platform or business organization.
• Acts as a mentor / role model for junior team members on technical issues.
• Ability to apply project leadership skills in planning, delegating, influencing, and managing priorities.
• Beginning todemonstrateleadership behaviors: humility, will, best team and vision.
• Demonstrates understanding ofcompany'sinternal and external customer needs and how they affect business unit products and services.
• Brings company and industry knowledge as well as creative technical/scientific skills to product creation; recognized as a content, sub-discipline specialist across the company.
• 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.
• Independently address routine issuesutilizingdocumented procedures and researching historical cases.
• Provide support and response to complex system problems, counseling the internal and external vendors and Laboratory Service Engineers on corrective and preventative actions.
• Provide mentoring and technical guidance to service engineers, laboratory technicians, and other members of the Process Development and Automation team.
• Maintain oversight for quality of both mechanical repairs and related documentation.
• Leadrecommendationand implementation changes to ensure ongoing high-quality performance of laboratory equipment.
• Lead technical investigation and troubleshooting of laboratory systems.
• Lead continuous improvement projects that drive cost reduction and lab efficiency.
• Ensure both new and existing instrumentation automation and non-automation meet safety requirements and compliance standards.
• Maintain records and follow laboratory procedures to meet regulatory requirements such as FDA, CLIA, and/or CAP.
• Maintain and continuously develop personal knowledge andexpertiserelated to the service of complex clinical laboratory equipment.
• Ability to manage time effectively between competing priorities.
• Excellent verbal and written English communication skills.
• Ability to manage and adhere to maintenanceschedule.
• Ability to define problems, collect data,establishfacts, and draw data driven conclusions.
• Havedemonstratedabilityto follow procedures andmaintaindetailed records.
• Havedemonstratedabilityto manage time and competing priorities.
• Must be highly motivated and able to work both independently and as a member of a team.
• Adaptable, open tochangeand able to work in ambiguous situations and respond tonew informationand unexpected circumstances.
• Proven capability to take scientific bench protocols from the bench to automation system.
• Effectively communicate issues/problems and results that impact timelines, accuracy, and reliability of data.
• A wide degree of creativity and latitude isexpectedincluding the ability to multi-task and work productively in a demanding environment with changing priorities.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support andcomply withthe company's Quality Management System policies and procedures.
• Regular and reliable attendance.
• Occasional evening and weekend work may berequired.
• Ability tolift upto 50 pounds for < 5% of a typical working day.
• Ability to work seated for approximately 80% of a typical working day.
• Ability to work standing for approximately 20% of a typical working day.
• Ability to work in front of a computer screen and/or perform typing for approximately 80% of a typical working day.
• Ability tocomply withall applicable personal protective equipment requirements.
• Ability to travel approximately 10% of working time for occasional training, out of state vendor site visits, and travel between Exact Sciences sites.

Minimum Qualifications

• Bachelor's degree in Engineeringor related field; orAssociates degree in Engineering, Technology, Electronics, or similar field and 2 years of experience.
• 6+ years of experience in engineering or relevant industry.
• Possesses advanced knowledge of engineering theories, practices and procedures and applies this knowledge and skills to complete assignments.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

• Bachelor's degree inClinical Laboratory Science, Medical Technology,Engineering or related field and 10+ years of relevant experience; or Associates degree inClinical Laboratory Science,MedicalTechnology, or similar field with 12+ years of relevant industry experience.
• 2+ years of experienceworking withlaboratory information management systems (LIMS)orintegratingLIMSwith automated systems.
• Experience in process optimization involving complex workflowscomprisingboth system equipment and software components to ensure user and business requirements are met.
• Experience working in a CAP/CLIA and/or other regulated production environment.
• Advanced knowledge ofdatabase, laboratory information management systems, and other file management applications.