Senior Medical Device Process Engineer - Growth & Impact

CREGG

Connacht

On-site

EUR 70,000 - 100,000

Full time

14 days+

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Job summary

CREGG in Galway seeks a Senior Process Development Engineer to design, develop and validate scalable manufacturing processes for medical devices. You will lead development projects, provide direct line support to manufacturing, and collaborate with production teams to troubleshoot, stabilize, and sustain daily performance.

The role is permanent with a full benefits package, requiring full authority to work in Ireland.

Qualifications

5+ years of relevant experience in engineering or related field.
Experience in medical device process development, manufacturing and project management.
Knowledge of ISO 13485 and FDA regulatory requirements.
Strong risk analysis, problem-solving and process validation skills.
Proactive team player with excellent organizational and interpersonal skills.

Responsibilities

Collaborate with engineers and production teams to develop and improve manufacturing processes.
Develop and implement manufacturing systems and strategies to meet cost, quality and time objectives while scaling output.
Lead automation initiatives and ensure integration with existing processes and regulatory standards.
Identify and drive Lean improvements and implement CAPA and continuous improvement actions.
Develop validation protocols and analyze results to make data-driven recommendations.
Prepare training materials and SOPs to transfer knowledge to production teams.