Manufacturing Engineer – Medical Device Validation

About the role

The Manufacturing Engineer will ensure that manufacturing equipment, systems and processes meet regulatory and company standards within the medical device sector. You will lead validation activities from planning through execution, guaranteeing compliance with FDA, ISO 13485 and cGMP requirements.

Key responsibilities

• Plan, execute and manage IQ, OQ and PQ protocols for manufacturing equipment.
• Lead qualification of new and existing equipment, ensuring proper installation and performance.
• Maintain compliance with cGMP and other relevant standards throughout validation.
• Provide technical expertise on equipment specifications, performance criteria and operational requirements.
• Conduct root cause analysis and drive CAPA actions for equipment issues.
• Develop, review and archive validation protocols, reports and SOPs.
• Ensure traceability and audit readiness for internal audits and regulatory inspections.
• Support regulatory filing preparation and review as needed.
• Participate in continuous improvement initiatives to optimise equipment performance and reduce waste.
• Mentor junior engineers and technicians on validation practices.

Required profile

• Experience in validation and qualification of manufacturing equipment in the medical device industry.
• Strong knowledge of FDA regulations, ISO 13485 and cGMP requirements.
• Proven ability to lead validation projects from conception to completion.
• Experience with root cause analysis, CAPA implementation and audit preparation.
• Ability to produce clear, compliant documentation and reports.

Required skills

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• cGMP compliance
• FDA regulatory knowledge
• ISO 13485 standards
• Root cause analysis
• CAPA development
• SOP creation and maintenance