Manufacturing Engineer
West Chester, OH - USA
Job Summary
About the Role:
The Manufacturing Engineer will support precision manufacturing process engineering and continuous improvement in a highly regulated production environment serving aerospace medical device and other quality-critical industries. This role is ideal for a hands-on Manufacturing Engineer Process Engineer or Aerospace Manufacturing Engineer with experience in CNC machining manufacturing process development quality systems and regulated standards such as AS9100 and ISO 13485. The engineer will work closely with production quality engineering and operations teams to improve manufacturability process capability quality cost and on-time delivery.
Responsibilities:
- Develop document implement and optimize manufacturing processes for precision-machined components used in aerospace medical device and other highly regulated applications.
- Create and improve manufacturing process plans work instructions routings tooling strategies fixtures process documentation and production methods for CNC machining operations.
- Support new product introduction NPI by reviewing engineering drawings specifications GD&T requirements tolerances materials and customer requirements to establish robust manufacturing processes.
- Apply Design for Manufacturability DFM principles to identify production risks recommend design or process improvements and improve cost quality throughput and repeatability.
- Lead continuous improvement initiatives using Lean Manufacturing root cause analysis corrective and preventive action CAPA 5 Why process capability and data-driven problem-solving methodologies.
- Partner with CNC programmers machinists quality engineers inspectors and production leadership to troubleshoot machining tooling dimensional and process-related issues.
- Support process validation first article inspection FAI process capability studies PFMEA control plans and other quality documentation required for regulated manufacturing.
- Ensure manufacturing processes and documentation comply with applicable quality management systems and industry requirements including AS9100 ISO 9001 ISO 13485 and customer-specific requirements.
- Analyze cycle times scrap rework tooling performance equipment utilization and production data to identify opportunities for productivity improvement and cost reduction.
- Support investigations of nonconforming material and customer quality issues by determining root causes implementing corrective actions and verifying effectiveness.
Qualifications:
- Bachelors degree in Manufacturing Engineering Mechanical Engineering Industrial Engineering or a closely related engineering discipline.
- Professional experience in manufacturing engineering process engineering or production engineering within precision machining aerospace manufacturing medical device manufacturing or another regulated manufacturing environment.
- Working knowledge of CNC machining processes including milling turning cutting tools fixtures workholding machining parameters and precision manufacturing practices.
- Ability to interpret complex engineering drawings specifications geometric dimensioning and tolerancing GD&T and tight tolerance requirements.
- Experience developing manufacturing processes work instructions process routings production documentation and standardized manufacturing methods.
- Knowledge of regulated quality systems and standards such as AS9100 ISO 9001 ISO 13485 or comparable aerospace and medical device manufacturing requirements.
- Experience with root cause analysis corrective action CAPA Lean Manufacturing continuous improvement and structured problem-solving techniques.
- Strong analytical and troubleshooting skills with the ability to work cross-functionally with manufacturing quality operations engineering and supply chain teams.
Desired Qualifications:
- Experience manufacturing complex tight-tolerance components for aerospace defense aviation medical device surgical or other highly regulated applications.
- Familiarity with aerospace first article inspection requirements including AS9102 FAI documentation traceability and configuration-controlled manufacturing processes.
- Experience with medical device quality systems process validation risk management PFMEA control plans and ISO 13485 requirements.
- Knowledge of CAD/CAM software CNC programming ERP/MRP systems statistical process control SPC and manufacturing data analysis.
- Experience applying Lean Six Sigma Kaizen 5S value stream mapping cycle-time reduction and other operational excellence methodologies.
- Demonstrated ability to lead manufacturing improvement projects from problem identification through implementation validation documentation and sustained production performance.