Senior Automation Engineer, R&D

$143,000 - $228,000/Yr

Exact Sciences - San Diego, CA

Full-time - Senior

San Diego, CA

Ambulatory Health Care Services

About the position

At Exact Sciences, we are dedicated to transforming the way the world prevents, detects, and guides treatment for cancer. As a Senior Automation Engineer in Research and Development (R&D), you will play a pivotal role in leading cross-functional product development projects for In Vitro Diagnostics (IVD) medical devices, from concept through to manufacturing. This position requires expert technical skills and the ability to conceive, plan, and execute R&D product development activities to meet project goals. You will leverage advanced engineering principles and methods, along with data-driven judgment, to influence product development activities effectively. In this role, you will develop and deploy robust laboratory automation solutions specifically for Next-Generation Sequencing based assays, supporting high complexity laboratory developed tests. Your technical expertise will be crucial in conceiving, planning, and executing research and development activities. The ideal candidate will have experience working collaboratively in a fast-paced team environment to build scalable, highly integrated automation platforms that enable users to deliver timely, high-quality results in a regulated environment. This position is based onsite at our San Diego office. You will be responsible for developing automated laboratory solutions that meet the requirements of existing assay workflows, iteratively designing and implementing automated liquid handler methods for high-throughput environments, and improving these methods based on experimental data and user feedback. Additionally, you will support the integration of automation software with external systems, assist in the design transfer and deployment of automation solutions across multiple sites, and train and mentor junior engineers. Your role will also involve maintaining and troubleshooting automated systems, participating in new product design, and ensuring compliance with applicable regulations and industry standards. You will lead Human Factors Engineering tasks, product risk management activities, and collaborate with the Quality team to establish documentation processes for systems engineering tasks.

Responsibilities

• Develop automated laboratory solutions to meet the requirements of existing assay workflows.
• Iteratively design, develop, and implement automated liquid handler methods for use in a high throughput environment, improving methods based on feedback from experimental data and user feedback.
• Support accurate and robust automation software integration with external systems (LIMS, integrated hardware, etc.) through the development of Installation and Operational Qualification procedures.
• Support design transfer and deployment of automation solutions across multiple sites which meet product requirements and are fully integrated with clinical laboratory workflows.
• Train, guide, and mentor junior level engineers.
• Assist and train laboratory personnel on the use of automated systems.
• Maintain and troubleshoot automated systems and processes.
• Participate in new product design and design improvements to existing products.
• Collaborate with cross-functional teams to ensure all development activities are conducted in adherence to applicable national/international regulations, guidelines, company policies, SOPs, and industry standards.
• Lead Human Factors Engineering/Usability Engineering tasks and activities.
• Lead product risk management activities involving system Hazard Analysis (HA) and Failure Modes and Effects Analysis (FMEA).
• Collaborate with Quality team to establish templates and processes for the documentation of systems engineering tasks and activities.
• Participate in the definition of key development deliverables, milestones, dependencies, risks, and mitigations as part of the Integrated Program Plan.
• Establish interfaces across other organizational groups.
• Apply strong analytical and problem-solving skills.
• 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.
• Maintain regular and reliable attendance.

Requirements

• Bachelor's Degree in Engineering or a related field as outlined in the essential duties.
• 8+ years of relevant experience in product development.
• 6+ years of experience with requirements development and risk management.
• 6+ years of experience working on projects with cross-functional technical teams through a formal phase gate or new product development process.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Benefits

• Paid time off (including days for vacation, holidays, volunteering, and personal time)
• Paid leave for parents and caregivers
• Retirement savings plan
• Wellness support
• Health benefits including medical, prescription drug, dental, and vision coverage