IL
Engineer Senior Manufacturing
ICONMA, LLC
- 🇺🇸 United States
- On-site
- Senior
- 1 day ago
- $42.44 – $45.72 / hour
- Six Sigma
- Lean
1 day ago
Not enough detail in this posting to match
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?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
Engineer Senior Manufacturing · ICONMA, LLC