Manufacturing Engineer | Norfolk, NE
Work Mode: 100% Onsite
Industry: Medical Devices / Healthcare
Required Skills:
Strong experience in Process Validation and Equipment Qualification (IQ/OQ/PQ)
Hands-on experience with PLM Agile, Change Orders, and DMCO
Knowledge of Change Management and Change Control processes
Understanding of medical device manufacturing, FDA regulations, and ISO 13485 requirements
Experience preparing and reviewing validation protocols, reports, risk assessments, and engineering studies
Knowledge of FMEA, CAPA, and deviation investigations
Experience in manufacturing transfer and process improvement
Strong cross-functional project coordination skills
Key Responsibilities:
Execute process validation and equipment qualification activities, including IQ/OQ/PQ.
Manage engineering change orders, DMCO, and change control documentation using PLM Agile.
Prepare and review validation protocols, reports, risk assessments, and engineering studies.
Support investigations, CAPA, FMEA, and manufacturing deviations.
Ensure compliance with FDA requirements, ISO 13485, and medical device quality standards.
Support manufacturing transfers, process improvements, and production activities.
Collaborate with cross-functional teams to ensure product quality and manufacturing efficiency.
Preferred Qualifications:
Experience in medical device manufacturing
Strong knowledge of Quality Management Systems (QMS)
Hands-on experience with validation documentation and manufacturing change control