Engineer Senior Manufacturing

Job Description

Job Description

Our Client, a Medical Device and Healthcare company, is looking for an Engineer Senior Manufacturing for their Madison, WI location.

• Support internal automation machines using Allen Bradley controls.  Make software updates to support troubleshooting, improvement projects, and quality improvements.
• Integrate machine software with cloud networking for Process Monitoring, dashboard creation and tracking metrics.
• 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.
• 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 between Exact Sciences sites located in Madison, WI.
• 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, 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.
• 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 (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.

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities