Medical Device Manufacturing Engineer
New Today
Job Title: Manufacturing Engineer
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Location: Newark, DE
Duration: Long Term Contract
Client: Medical Device Industry
Our client is seeking an experienced Manufacturing Engineer to support remediation activities at its site Delaware site. This role is hands-on, floor-facing, and focused on stabilizing and remediating capital equipment manufacturing processes. The ideal candidate can step in on day one and work cross-functionally to assess process risk, validate controls, and ensure manufacturing processes are properly documented, mitigated, and executed in compliance with the Quality Management System.
Key Responsibilities
• Support remediation activities within manufacturing operations, with a focus on capital and electromechanical products
• Perform detailed process risk analysis, reviewing and scrubbing PFMEAs to ensure all process steps, failure modes, and mitigations are accurately identified and implemented
• Evaluate manufacturing processes end-to-end, confirming that identified mitigations are appropriate, effective, and reflected in procedures and work instructions
• Assess validation status across manufacturing processes, including IQ/OQ/PQ and Test Method Validation (TMV), ensuring downstream verification strategies are accurate and defensible
• Review and update manufacturing documentation, xsgimln including procedures, work instructions, and DHF elements, to ensure alignment between documented processes and actual production practices
• Partner closely with Manufacturing, Quality, and Engineering teams to close gaps, implement corrective actions, and drive sustainable remediation outcomes
• Support manufacturing areas involving dimensional inspection, detection systems, and capital equipment, then expand remediation support across additional processes as needed
- Location:
- Newark
- Category:
- Healthcare And Medical