Senior Automation Engineer R&D

Exact Sciences-posted 3 months ago
$102,350 - $173,650/Yr
Full-time • Senior
San Diego, CA
Computer and Electronic Product Manufacturing
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The Senior Automation Engineer R&D is a key problem solver and a potential core team leader to plan and lead cross-functional product development projects for In Vitro Diagnostics (IVD) medical devices from concept to manufacturing. This position will use expert technical skills, conceive, plan and lead R&D product development activities to achieve project goals. This position will leverage understanding of advanced engineering principles, advanced engineering methods, data, and judgment to influence the course of product development activities. The Senior Automation Engineer R&D will develop and deploy robust laboratory automation solutions for Next-Generation Sequencing based assays in support of high complexity laboratory developed tests. This position will utilize technical skills, with oversight, to participate in conceiving, planning, and executing research and development activities to achieve project goals. The successful candidate has experience working in a collaborative, fast-paced team to build scalable, highly integrated automation platforms which enable users to reliably and efficiently deliver timely, high-quality results in a regulated environment. This position is onsite at our San Diego office.

  • 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, improve 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) 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.
  • Ability to act with an inclusion mindset and model these behaviors for the organization.
  • Bachelor's Degree in Engineering or 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.
  • 6 years of Hamilton Venus scripting experience.
  • Experience working with HSL code.
  • Worked on integration in workcells/end-to-end platforms.
  • 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
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