Lead Pre-Analytical Process Engineer

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Position Overview

The Lead Engineer, Process Development and Automation leads, manages, implements, and provides technical engineering support for a variety of process automation hardware, software applications, and laboratory instruments. 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. The Lead Engineer, Process Development and Automation responsibilities may include guiding Lab Service, Process Development and Automation and Laboratory Operations teams in the process of selecting automation, system design, integration, commissioning, and project documentation. This role's influence extends to the technical, quality, and business teams, as well as the other engineers within laboratory operations.

The Lead Engineer will work both independently and within teams to drive process improvements to facilitate lab efficiency and assay growth. This includes mapping and evaluating existing workflows, process optimization, automation, and lab systems integration. This role requires strong understanding of pre-analytical laboratory operations, including clinical test sample accessioning and histopathology workflows.

Essential Duties

include but are not limited to the following:

• Applies in-depth knowledge to key technical and testing activities; conceives and directs / conducts experiments, or engineering studies used to make significant tactical, strategic and compliance decisions.

• Collaborates and negotiates deliverables with other functional organizations.

• Develops complex process architectures and functional specifications based on user and workflow requirements. Plans and directs / conducts complex engineering design, platform eligibility testing, systems integration, and performance / validation testing.

• Provides expert input into technical decisions and recommendations.

• Solves unusual or highly technical/scientific problems.

• Provides input to senior management for making strategic & functional decisions.

• Helps senior management develop decision-making guidelines and problem-solving techniques.

• Communicates and influences decisions across multiple functional areas and platforms.

• Evaluates and sells alternative solutions, effectively influencing outcomes.

• Ability to work with Sr. Management on product development initiatives.

• Actively and constructively contributes to other's designs through design reviews across multiple platforms.

• Facilitates reuse by communicating available technologies and opportunities across organizations.

• Ability to lead major project teams and major cross-organizational programs.

• Recognized as an expert resource on issues across projects and product lines.

• Role model in organization for project management, communication, and cross-group influence.

• Teaches and mentors others on technical and other development issues.

• Regularly demonstrates leadership behaviors: humility, will, best team and vision.

• Applies company knowledge and industry expertise to assist senior management with leading product development.

• Develops new products and technologies for emerging and existing markets.

• 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.

• Work with business stakeholders to define strategy and requirements to define and execute a collection of projects across the business.

• Lead and coach multiple efforts and teams to deliver work successfully.

• Independently address routine issues utilizing documented procedures and researching historical cases.

• Drive 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 other process and development engineers, the service engineering team and laboratory technicians.

• Lead recommendation and implementation of 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 valid 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 with 2+ years of relevant industry experience.

• 8+ years of experience in engineering or relevant industry.

• 2+ years of experience leading and developing projects or colleagues.

• Authorization to work in the United States without sponsorship.

• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

• Advanced knowledge of engineering theories, practices and procedures and applies this knowledge and skills to complete assignments.

• Extensive experience in process optimization involving complex workflows comprising both system equipment and software components to ensure user and business requirements are met.

• Successful track record of leading projects from inception to successful implementation with cross-functional participation.

Preferred Qualifications

• Strong understanding of pre-analytical clinical laboratory operations

• Experience working directly with clinical sample accessioning procedures is highly desired

• Experience with histology processes and techniques including tissue handling, sectioning, staining and analysis

• Knowledge of digital pathology technologies and image analysis tools will be valuable in driving process improvements

• Technical proficiency and experience in automation and system development and integration in a laboratory environment.

• Experience working in a CAP/CLIA and/or other regulated production environment.

• Working knowledge of database, laboratory information management systems, and other file management applications.

• Lean six-sigma training or certification.

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Salary Range:

$175,000.00 - $278,000.00

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, and is eligible to receive company stock upon hire as well as annually.

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 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. Any applicant or employee may request to view applicable portions of the company's affirmative action program.

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