Medical Device Manufacturing Engineer

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Job Title: Manufacturing Engineer
To be considered for an interview, please make sure your application is full in line with the job specs as found below. 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