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Engineer Senior Manufacturing

ICONMA, LLC
  • Madison, WI
  • $42.44–$45.72 Per Hour
  • Instant Apply
1 day ago

Job Description

Our Client, a Medical Device and Healthcare company, is looking for an Engineer Senior Manufacturing for their Madison, WI location.
 
Responsibilities:
  • 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.
 
Requirements:
  • 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.
 
Why Should You Apply?

Numbers & Facts

LocationMadison, WI
Salary$42.44–$45.72 Per Hour

Skills

  • Allen-Bradleyunmatched
  • Automationunmatched
  • Biologyunmatched
  • Budget Managementunmatched
  • Budgetingunmatched
  • Cloud Computingunmatched
  • Continuous Improvementunmatched
  • Corrective Actionunmatched
  • Cost Controlunmatched
  • Cross-Functionalunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Data Analysisunmatched
  • Documentationunmatched
  • Electronicsunmatched
  • Engineeringunmatched
  • Equipment Maintenance/Repairunmatched
  • Establish Prioritiesunmatched
  • FDA (Food and Drug Administration)unmatched
  • Failure Analysisunmatched
  • Health Planunmatched
  • Healthcareunmatched
  • ISO (International Organization for Standardization)unmatched
  • Identify Issuesunmatched
  • Leadershipunmatched
  • Lift/Move 50 Poundsunmatched
  • Manufacturingunmatched
  • Manufacturing Softwareunmatched
  • Manufacturing Systemsunmatched
  • Matrix Managementunmatched
  • Medical Equipmentunmatched
  • Metricsunmatched
  • Network Monitoringunmatched
  • Problem Solving Skillsunmatched
  • Procedure Developmentunmatched
  • Process Developmentunmatched
  • Process Improvementunmatched
  • Product Designunmatched
  • Product Supportunmatched
  • Product/Service Launchunmatched
  • Production Systemsunmatched
  • Project Developmentunmatched
  • Project Estimatesunmatched
  • Project Planningunmatched
  • Project/Program Managementunmatched
  • Quality Managementunmatched
  • Record Keepingunmatched
  • Regulationsunmatched
  • Reporting Dashboardsunmatched
  • Root Cause Analysisunmatched
  • Six Sigmaunmatched
  • Software Administrationunmatched
  • Statisticsunmatched
  • Team Playerunmatched
  • Testingunmatched
  • Time Managementunmatched
  • Typingunmatched
  • Willing to Travelunmatched

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