Hybrid Manufacturing Engineer - Medical Devices

CREGG; Galway; Hybrid; Confidential; Full time

Job summary

CREGG is seeking a Manufacturing Engineer for Galway in a hybrid role within the medical device sector. The position focuses on partnering with manufacturing and quality teams to support process validation, NPI and continuous improvement, ensuring compliance and robust technical documentation.

You will work with cross-functional teams to drive CAPA resolutions, SOPs, and lean manufacturing initiatives while maintaining audit readiness and collaborating on supplier and regulatory interfaces.

Qualifications

• Degree in Engineering or related discipline.
• 2+ years of experience in medical device/pharma manufacturing.
• Background in IQ/OQ/PQ validation and CAPA resolution.
• Excellent technical writing and documentation abilities.
• Solid understanding of GMP/med device regulatory requirements.
• Strong problem-solving mindset and cross-functional collaboration.

Responsibilities

• Collaborate with manufacturing and cross-functional teams to close gaps and drive compliance.
• Execute IQ/OQ/PQ validation activities and support NPIs.
• Revise and maintain quality records and technical documentation for audit readiness.
• Liaise with suppliers and vendors on NPI and equipment procurement.
• Lead CAPA and NCR closures with robust corrective actions.
• Develop clear SOPs and manufacturing process documentation.
• Support lean manufacturing and process improvement projects.
• Coordinate with Manufacturing, Quality, and Regulatory to deliver sustainable solutions.

Skills

Process validation

CAPA resolution

Technical writing

Cross-functional collaboration

Regulatory knowledge GMP

Lean manufacturing

Education

Engineering degree

Job description

CREGG is seeking a Manufacturing Engineer for Galway in a hybrid role within the medical device sector. The position focuses on partnering with manufacturing and quality teams to support process validation, NPI and continuous improvement, ensuring compliance and robust technical documentation.

You will work with cross-functional teams to drive CAPA resolutions, SOPs, and lean manufacturing initiatives while maintaining audit readiness and collaborating on supplier and regulatory interfaces.