Senior Manufacturing Operations Manager
3 weeks ago
We are looking for a highly skilled Senior Manufacturing Engineer to lead our manufacturing operations. If you have experience in Lean manufacturing, Six Sigma, and leadership, we want to hear from you
About Us:
Coghlin Companies Inc. is a leading manufacturer of medical devices. We are committed to delivering high-quality products and providing exceptional customer service.
Job Description:
The Senior Manufacturing Engineer will be responsible for providing leadership and mentoring to our manufacturing team. This includes developing and implementing Lean manufacturing processes, conducting Root Cause Analysis (RCA), and creating Value Stream Maps (VSM).
Responsibilities:
- Lead by example and promote strict compliance adherence.
- Develop and implement Lean manufacturing processes.
- Conduct RCA and create VSM.
- Collaborate with departments to analyze customer ECOs and implement changes.
- Oversee customer BOM structure and supplier relationships.
- Define PP/PA/Phantom, Commodity codes, and documentation packages.
- Generate and update DMR Indexes for accuracy.
- Provide ECO final approval for release.
- Oversee ECO implementation performance metrics.
- Effectively interact with customers and internal departments to create value add propositions.
- Identify trends and process gaps, and suggest corrective actions and process improvements.
- Collaborate to determine root cause of customer issues, Complaints, and CAPAs.
- Oversee ME responses to manufacturing floor quality issues.
- Develop and approve optimal work order routings and Device History Records.
- Lead complex troubleshooting efforts and generate Rework Instructions.
- Oversee Lean Manufacturing Cells and quality and inspection plans.
- Regularly audit calibrated tools and floor stock items.
- Train Assembly Technicians and Test Technicians on procedures.
- Manage Scaled Product Launch/transitions and process validation/qualification documentation.
- Evaluate Product Performance Data and Internal Metrics for stability and continuous improvements.
- Generate Manufacturing Engineering Bulletins and contribute to DFcx exercises.
- Oversee Risk analysis, Risk management, and Risk reports.
- Lead and oversee co-build activities and nonconforming product containment.
- Approve rework instructions and non-conformances.
- Review and approve Equipment enrollment forms.
- Train Manufacturing Engineers and Engineering Document Control Specialists.
Requirements:
- Positive attitude and self-motivator with tenacious follow up.
- Superior customer service attitude and excellent teamwork, communication, and leadership skills.
- Exceptional attention to detail and strong electro-mechanical and opto-mechanical orientation.
- Experience in ISO 13485 certified and cGMP organizations preferred.
- Proven problem solver with multitasking skills and ability to prioritize tasks.
- Knowledge of IPC 610 and 620 standards beneficial.
- Bachelor's degree in science, engineering, or manufacturing discipline required.
- 8 or more years of related manufacturing experience and technical document control may be considered in lieu of certain educational requirements.
- 10+ year's professional experience in medical subassembly and finished device manufacturing preferred.
- Advanced Level Skills in MS Word, Excel, and PowerPoint preferred.
- SolidWorks and PDM experience is preferred.
- Advanced working knowledge of Lean concepts and Six Sigma Black Belt training is preferred.
Estimated Salary:$140,000 - $180,000 per annum, based on experience.
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