Manufacturing Engineer II: Process & Validation Innovator

Aerogen Ltd.; Shannon; Remote; EUR 52.000 - 76.000; Vollzeit

Benefits dieser Stelle

Excellent medical care

Bonus & Pension

Aerogen Connect programme

Charity & community involvement

Zusammenfassung

Aerogen Ltd. in Galway, Ireland, is seeking a Manufacturing Engineer II to drive product, process and sustainability improvements across the business.

You will identify opportunities, use data analytics and lead cross-functional teams to deliver robust solutions that enhance manufacturing performance. You will lead cross-functional projects, develop and validate manufacturing processes and collaborate with R&D, quality and operations to ensure successful lifecycle delivery.

Qualifikationen

• Level 8 engineering/technology degree and minimum 3 years' relevant experience.
• Experience in medical device manufacturing with ISO 13485, EU-MDR, MDSAP or FDA familiarity.

Aufgaben

• Lead cross-functional projects to deliver process improvements.
• Introduce new manufacturing processes within teams.
• Develop and validate processes and equipment including DV/IQ/OQ/PQ.
• Support PFMECA, BOM creation and documentation.
• Plan and manage project scoping, risks, costs and schedules.
• Collaborate with vendors to improve processes and capabilities.
• Troubleshoot issues with cross-functional teams in CI.
• Communicate across R&D, operations, quality, sales, marketing through lifecycle.

Kenntnisse

Design verification

Process validation

Root cause analysis

Data analysis

Project planning

Organizational skills

Team collaboration

Leadership

Regulatory knowledge

MS Office

Travel willing

Ausbildung

Level 8 qualification in Engineering, Technology or Science

Tools

Regulatory frameworks

Jobbeschreibung

Aerogen Ltd. in Galway, Ireland, is seeking a Manufacturing Engineer II to drive product, process and sustainability improvements across the business.

You will identify opportunities, use data analytics and lead cross-functional teams to deliver robust solutions that enhance manufacturing performance. You will lead cross-functional projects, develop and validate manufacturing processes and collaborate with R&D, quality and operations to ensure successful lifecycle delivery.