Sr. Equipment and Automation Engineer - 1st Shift

Exact Sciences • Madison, WI

16d • $91,000 - $155,000

About The Position

Our Mission 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 Senior Engineer, within the Corporate Operations department, is primarily responsible for leading design transfer efforts of new equipment from R&D, working with integrators to develop new machines for supporting production requirements, and provide manufacturing support for existing equipment. This position will participate in a variety of engineering design functions, provide technical guidance to the production teams, manage improvements, and ensure our machines are properly supported throughout their life. This position will work cross functionally with multiple departments to ensure that the business objectives and our customer needs are met. 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 mechanical engineer with design experience in a highly regulated industry, and good communication skills looking to make an impact in the fight against cancer.

Requirements

• Bachelor’s degree in Engineering with 5+ years of experience; or, in lieu of Bachelor's degree, Associates degree in Engineering, Technology, Electronics, or similar field with 7+ years of experience.
• Effectively applies Engineering skills to complete assignments.
• Demonstrated ability to identify opportunities for improvement, clearly define project scope, and complete projects on time and on budget.
• Demonstrated ability to plan projects, balance multiple competing priority projects, and drove projects to successful completion.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Nice To Haves

• 5+ years of experience in engineering or relevant life sciences / medical device industry.
• 5+ years of experience working in manufacturing or engineering environments applying problem solving skills (e.g., Six Sigma, probability and statistics) and process improvement (e.g. Lean).
• 5+ years of experience working in an FDA/cGMP/CAP/CLIA regulated production environment.
• 5+ years of experience working with Electronic Quality Management Systems and Manufacturing Software Systems.
• 2+ years of experience managing projects.

Responsibilities

• Develop processes and procedures for new equipment.
• Apply defined procedures to execute and document changes to existing equipment.
• Identify, create, document, and execute protocols to support process or part changes.
• Define improvement opportunities, investigate issues, gather facts, analyze data, and draw accurate data-driven conclusions.
• Troubleshoot and repair equipment.
• Lead failure analysis investigations, identify root cause analysis, and develop solutions to resolve quality issues in a timely manner.
• Lead or support product non-conforming material reports, corrective and preventative actions, investigations, audits, or complaints.
• Document in accordance with applicable regulatory requirements.
• Provide subject matter expertise for custom equipment and processes.
• Lead or support new product introductions, design transfers, and product changes.
• Create documentation records per regulatory and quality requirements.
• Lead continuous improvement projects.
• Support the building and testing of custom equipment.
• Provide manufacturing support for the repair center.
• Identify opportunities, analyze data, and work with cross functional teams to implement solutions that improve production quality, capability, reliability, or reduce costs.
• Develop project plans, delegate effectively, and execute assigned tasks.
• Prioritize assignments and work independently with minimal guidance from leadership.
• Provide clear and concise documentation and communication of project needs, scope, budget, and status to peers and leadership.
• Follow procedures and maintain detailed records in accordance with FDA, ISO, CAP, CLIA requirements.
• Ability to 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 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.
• Other duties as assigned.

Benefits

• paid time off (including days for vacation, holidays, volunteering, and personal time)
• paid leave for parents and caregivers
• a retirement savings plan
• wellness support
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees