Manufacturing Engineer II: Data-Driven Process Improvement

Aerogen Ltd.; Galway; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Aerogen Ltd. in Galway is seeking a Manufacturing Engineer II to drive the delivery of product and process improvements across manufacturing teams.

You will lead cross-functional projects, develop and validate processes, and support QA, sustainability, and supplier changes, with a focus on data analysis, problem solving and continuous improvement in a medical device environment. Expect travel up to 10% to vendor sites and manufacturing sites as required.

Qualifications

• Knowledge of design verification and process validation frameworks.
• Strong problem-solving capability with root cause analysis.
• Data analysis and reporting with attention to detail.
• Project planning and delivery with risk management.
• Experience in medical device manufacturing and compliance with EN ISO 13485:2016, EU-MDR, MDSAP and FDA requirements.

Responsibilities

• Work within cross-functional teams to introduce new manufacturing processes.
• Lead and contribute to cross-functional quality, sustainability, vendor change and cost improvement projects from initiation to delivery.
• Execute and support process and equipment development and validations including DV, IQ, OQ, PQ, PPQ, TMV with protocol development and data analysis.
• Support operational readiness activities including manufacturing documentation, PFMECA, and BOM creation.
• Collaborate with R&D, operations, quality, sales and marketing through the product and process development lifecycle.
• Travel to manufacturing and vendor sites to support service and project activities (up to 10%).

Skills

Design verification

Process validation

Root cause analysis

Data analysis

Project planning

Organization

Collaboration

Leadership

Regulatory standards

MS Office

Travel readiness

Education

Level 8 qualification in Engineering, Technology or Science

Job description

Aerogen Ltd. in Galway is seeking a Manufacturing Engineer II to drive the delivery of product and process improvements across manufacturing teams.

You will lead cross-functional projects, develop and validate processes, and support QA, sustainability, and supplier changes, with a focus on data analysis, problem solving and continuous improvement in a medical device environment. Expect travel up to 10% to vendor sites and manufacturing sites as required.