JOB DESCRIPTION:

Position Overview

The Sr. Equipment and Automation Engineer is primarily responsible for design transfer of new medical devices and providing manufacturing support for the existing medical devices. This position will participate in a variety of engineering functions, including but not limited to design changes, design reviews, supplier qualifications, risk assessments, and creating proper documentation to support GMP requirements. This is an ideal role for a hands-on mechanical engineer with good communication skills looking to make an impact in the fight against cancer.

Essential Duties

Include but are not limited to the following:
• Lead or support new product introductions, design transfers, and product changes.
• Create documentation records per regulatory and quality requirements.
• Develop processes and procedures for new equipment.
• Create and update Solidworks parts, drawings, and assembly files.
• Maintain the Solidworks PDM library for new and updated files.
• Lead or participate in design reviews and risk assessments.
• 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.
• 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 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.

Minimum Qualifications:
• Bachelor's degree in Engineering with 5+ years of experience; or, in lieu of Bachelor's degree, Associates degree in Engineering, Technology, CAD design, 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 drive 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.

Preferred Qualifications
• 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 and process improvements.
• 2+ years of experience managing projects.

The base pay for this position is
$78,000.00 - $156,000.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Engineering

DIVISION:
ONCO Cancer Diagnostics

LOCATION:
United States > Madison : 1 Exact Lane

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 5 % of the Time

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)