Staff Engineer

Help us change lives

At Exact Sciences were helpingchange 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 youre 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.

ThisStaff 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.
• Leaduser acceptance testing (UAT)ofnew and changes to Laboratory IT systems includingvalidation of LaboratoryInformationSystem (LIS) system changes and upgrades.
• Coordinates manages implements and provides technical engineering support for a variety ofautomationIT andsoftware applications andinstrumentsused in the clinical laboratory.

Essential Duties

Include but are not limited to the following:

• LeadsUser Acceptance Testing (UAT)includingIT systemspreparationsample coordination test case generation/review and documentpreparation 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 complexplatform eligibility testing systems integration or performance 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.
• 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.
• 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 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 toothersdesigns through design reviews withinsameorganization.
• 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 todemonstrateleadership behaviors: humility will best team and vision.
• Demonstrates understanding ofcompanysinternal 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.
• 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.
• 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 dataestablishfacts 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 companys 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

• Bachelors degree in Engineering or related field; or Associates degree in Engineering Technology Electronics or similar field and 2 years of relevant work experience.
• 8 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

• Bachelors degree inClinical Laboratory Science Medical Technology Biological SciencesEngineering or related field and 4 years of relevant experience; or Associates degree inClinical Laboratory ScienceMedicalTechnology 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.

Salary Range:

$142000 - $200000

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation holidays volunteering and personal time) paid leave for parents and caregivers a retirement savings plan wellness support and health benefits including medical prescription drug dental and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation please contact us here.

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