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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 creative technical/scientific skills to product creation; recognized as a content, sub-discipline specialist across the company.
- Independently address routine issues utilizing documented 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.
- Lead recommendation and 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 and expertise related 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 maintenance schedule.
- Ability to define problems, collect data, establish facts, and draw data driven conclusions.
- Have demonstrated ability to follow procedures and maintain detailed records.
- Have demonstrated ability to manage time and competing priorities.
- Must be highly motivated and able to work both independently and as a member of a team.
- Adaptable, open to change and able to work in ambiguous situations and respond to new information and 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 is expected including 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 and comply with the company’s Quality Management System policies and procedures.
- Regular and reliable attendance.
- Occasional evening and weekend work may be required.
- Ability to lift up to 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 to comply with all 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 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
- Bachelor’s degree in Clinical Laboratory Science, Medical Technology, Biological Sciences, Engineering or related field and 4+ years of relevant experience; or Associates degree in Clinical Laboratory Science, Medical Technology, or similar field with 12+ years of relevant industry experience.
- 2+ years of experience working with laboratory information management systems (LIMS) or integrating LIMS with automated systems.
- Experience in process optimization involving complex workflows comprising both 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 of database, laboratory information management systems, and other file management applications.
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Salary Range:
$142,000 - $200,000
The annual base salary shown is for this position located in US - CA - Redwood City on a full-time basis. In addition, this position is bonus eligible.
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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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.
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