Manufacturing Engineer – Medical Device Validation

About the role

We are seeking a Manufacturing Engineer to lead equipment and process validation (IQ/OQ/PQ) for a medical‑device production facility in Marietta, GA. The role ensures that manufacturing systems meet FDA, ISO 13485 and GMP requirements while supporting production readiness.

Key responsibilities

• Execute Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for manufacturing equipment and processes.
• Develop, review and author validation protocols and reports in compliance with FDA and ISO standards.
• Coordinate with Quality, R&D, Production and Validation teams to ensure successful validation execution.
• Support equipment installation, commissioning, troubleshooting and clean‑room integration.
• Maintain GMP compliance, perform risk assessments (FMEA) and drive continuous process improvements.
• Ensure accurate documentation, traceability and validation records for audits and regulatory submissions.

Required profile

• Bachelor’s degree in Mechanical, Electrical, Biomedical or Manufacturing Engineering or equivalent.
• Minimum 3 years of experience in equipment qualification and process validation within a regulated environment.
• Strong knowledge of FDA regulations, ISO 13485 and GMP requirements.
• Proven ability to read engineering drawings, P&IDs and technical specifications.
• Excellent analytical, problem‑solving and communication skills.

Required skills

• IQ/OQ/PQ methodology and validation lifecycle.
• FDA regulatory compliance and ISO 13485.
• Good Manufacturing Practices (GMP), CAPA and change control.
• Risk assessment tools (FMEA).
• Statistical analysis and validation software.
• Automation system support and clean‑room manufacturing.