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Senior Manufacturing Engineer
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Overview
Job Description
- Position Type: Contract
- Contract Duration: 9 months
- Start: As Soon As Possible
- Pay Rate: $70–75/Hr
- Develop and execute validation plans including IQ, OQ, and PQ for manufacturing processes and process equipment.
- Lead implementation of sustaining engineering initiatives within manufacturing operations.
- Identify and execute process improvement opportunities using Lean methodologies.
- Translate complex technical issues into clear summaries for cross-functional stakeholders.
- Lead troubleshooting and root cause analysis efforts to resolve manufacturing challenges.
- Develop and update manufacturing documentation including process flowcharts, PFMEA, and process control plans.
- Facilitate Lean initiatives including kaizen events and continuous improvement programs.
- Coordinate with contract manufacturing partners to ensure processes follow established plans and risk mitigation strategies.
- Collaborate with R&D, procurement, design quality assurance, regulatory affairs, and field service teams.
- Work with suppliers and quality engineering teams to resolve supplier quality issues.
- Monitor product quality performance and field feedback to identify trends and implement corrective actions.
- Ensure compliance with organizational quality systems and regulatory requirements.
- Bachelor’s degree in Engineering (Mechanical, Electro-Mechanical, Electrical, Industrial, or related field).
- Minimum 7+ years of experience in manufacturing or manufacturing engineering.
- Experience supporting electromechanical product manufacturing.
- Experience performing manufacturing validations and developing validation protocols and reports.
- Experience leading cross-functional technical initiatives.
- Experience working in the medical device industry.
- Experience working with contract manufacturers and supplier quality management.
- Experience supporting sterile disposable product manufacturing.
- Manufacturing process validation (IQ/OQ/PQ)
- Lean manufacturing methodologies
- Manufacturing troubleshooting and root cause analysis
- Product lifecycle management systems (AGILE)
- ERP systems such as Oracle, SAP, or BAAN
- LabVIEW development or integration
- SolidWorks or other computer-aided design tools
- Statistical process analysis and validation documentation
- Lean methodologies including 5S, Kanban, SMED, and Value Stream Mapping
- GEMBA-based operational improvement techniques
- KPI development and manufacturing performance tracking
- Process control plan development
- Supplier quality management and corrective actions
- PFMEA development and risk management processes
- Cross-functional collaboration across engineering and regulatory teams
- Continuous improvement and process optimization strategies
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
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