Position Overview
Our Mission at Exact Sciences is to eradicate cancer and the suffering it causes – through tests that help prevent it, detection that finds it earlier, and guidance for its successful treatment. Come join our team and make a difference in other people’s lives.
The Staff Equipment and Automation Engineer, within the Corporate Operations department, is the technical subject matter expert in their area of expertise. They will be responsible for leading new product introductions and design transfer efforts of new equipment from R&D, as well as providing guidance for improvements to existing equipment. This position will be responsible for leading cross-functional teams in a matrix organization to plan and successfully execute larger projects. An emphasis will be on new pieces of equipment, supporting efforts to specify, develop, procure, document, install, commission, and execute projects within scope, on time, and on budget. This position supports a collaborative environment that promotes positive teamwork where all members are working for the good of Exact Sciences. This is an ideal role for a hands-on engineer with excellent communication skills looking to make an impact in the fight against cancer.
Essential Duties
- Develop processes and procedures for new equipment.
- Represent Engineering in cross-functional initiatives, as assigned, and act on behalf of the department as appropriate.
- Manage new product introductions, design transfers, and product changes to ensure optimal implementation into production.
- Identify opportunities, analyze data, and work with cross functional teams to implement solutions that improve production quality, capability, reliability, or reduce costs.
- Determine design specifications, builds prototypes, tests equipment, and critically evaluates design concepts for functionality, reliability and manufacturability.
- Lead or support cross-functional teams on new equipment by providing technical expertise in implementing engineering controls, performing risk assessments and design reviews, supporting installations, and executing commissioning protocols.
- Support new product introductions by collaborating with R&D, Operations, and/or Lab teams to ensure design for manufacturability elements are incorporated into product requirements.
- Facilitate development activities to facilitate smooth transfer of products and processes into new or existing automation systems.
- Create documentation records per regulatory and quality requirements.
- Support existing equipment by providing equipment set up and adjustment, hands-on troubleshooting, repair, planned maintenance, and performance monitoring in a Good Manufacturing Practice environment.
- Identify, document, gain approval for, execute, manage, and communicate on projects of higher scope and complexity.
- Provide clear and concise documentation and communication of project needs, scope, budget and status to peers and leadership.
- Estimate and create schedules, determine test plans, and track progress to plan.
- Set the vision and technical direction of project teams with minimal guidance from leadership.
- Provides guidance to junior members of the team.
- Lead or participate in investigations of manufacturing processes associated with internal review, Corrective and Preventative Actions, audits, or complaints.
- Act as technical leader for one or more projects that are complex in scope at one time, while navigating and adapting to ambiguous and changing plans and circumstances.
- Proactively prioritizes workload and delegates effectively to meet project deliverables.
- Work on problems which are extremely complex in scope in which analysis of data requires an evaluation of intangible variables.
- Demonstrate advanced investigative, analytical, deductive, and problem-solving skills.
- Excellent oral and written communication skills, with strong attention to detail and record keeping skills required in a GMP environment.
- Work independently and as part of a team within a matrix organization.
- 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.
- Ability to work designated schedule.
- Ability to lift up to 50 pounds for <5% 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 any 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.
- Other duties as assigned.
Minimum Qualifications
- Bachelor’s degree in engineering with 8+ years of experience, or, in lieu of Bachelor’s degree, Associate degree in Engineering, Technology, Electronics, or similar field with 10+ years of experience.
- Demonstrated ability to identify opportunities for improvement, reduce ambiguity by clearly defining project scope, and successfully complete projects with increasing complexity and size.
- Demonstrated ability to effectively plan projects, balance multiple competing priority projects, and lead medium to large scale projects to successful completion through disciplined project management methodology and tools.
- Experience in specifying, selecting, designing, and integrating components and manufacturing systems to solve business problems.
- Demonstrated ability to mentor less experienced engineers.
- 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
- Experience in projects that include integration of biological systems with automation and software applications in the life sciences, biotechnology, diagnostics, pharmaceutical, or medical device field.
- Experience working in an FDA/cGMP/CAP/CLIA regulated production environment.
- 5+ years of experience working with Electronic Quality Management Systems (Agile) and Manufacturing Software Systems (SAP).
