MedTech Manufacturing Engineer-Design & Process Validation

The Udder Group; Shannon; In loco; EUR 60.000 - 90.000; Tempo pieno

Vantaggi offerti da questo lavoro

Excellent medical care

Aerogen Connect

Charitable giving

Descrizione del lavoro

Aerogen, Galway-based leader in acute care aerosol drug delivery, seeks an experienced engineer to support design verification and process validation in medical device manufacturing. You will help solve complex quality issues, analyze data, plan projects, and ensure compliance with EN ISO 13485, EU‑MDR, MDSAP and FDA requirements, including travel to vendor sites up to 10%.

Join a global team committed to delivering better patient outcomes, with strong collaboration, leadership opportunities and

Competenze

• Level 8 qualification in Engineering, Technology or Science.
• A minimum of 3 years’ relevant experience.
• Knowledge of EN ISO 13485:2016, EU-MDR, MDSAP and FDA requirements.

Conoscenze

Design verification

Process validation

Root cause analysis

Data analysis

Project planning

Organisational skills

Leadership

Regulatory knowledge

MS Office

Travel readiness

Formazione

Level 8 qualification in Engineering/Tech/Science

Descrizione del lavoro

Aerogen, Galway-based leader in acute care aerosol drug delivery, seeks an experienced engineer to support design verification and process validation in medical device manufacturing. You will help solve complex quality issues, analyze data, plan projects, and ensure compliance with EN ISO 13485, EU‑MDR, MDSAP and FDA requirements, including travel to vendor sites up to 10%.

Join a global team committed to delivering better patient outcomes, with strong collaboration, leadership opportunities and