Manufacturing Leadership Position
20 hours ago
Coghlin Companies Inc. is seeking a seasoned Senior Manufacturing Engineer to join our team. This is a full-time position with a competitive salary and benefits package.
">About the Job:
The Senior Manufacturing Engineer will be responsible for providing engineering, operational, Lean manufacturing, and Six Sigma leadership and mentoring. The ideal candidate will have exceptional attention to detail, strong electro-mechanical and opto-mechanical orientation, and experience in ISO 13485 certified and cGMP organizations.
Key Responsibilities:
- Provide engineering, operational, and Lean manufacturing leadership and mentoring.
- Lead by example and promote strict compliance adherence.
- Train personnel on workmanship and quality standards.
- 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.
Salary:$140,000 - $180,000 per annum, depending on experience.
Benefits:
- Comprehensive health insurance.
- Retirement savings plan.
- Generous paid time off.
- Professional development opportunities.
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