Senior Design Assurance Engineer - Drug Delivery Devices

Valtera Group Ltd; Dublin; Hybride; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Valtera Group Ltd. in Dublin, Ireland, is seeking a Senior Design Assurance Engineer/Scientist to own design control for a portfolio of drug delivery devices from planning through approval. The role emphasizes challenging decisions, solving problems and signing off on critical design activities within a GMP environment.

We require 5+ years in device design and development, strong ISO/CFR knowledge, and a collaborative, proactive mindset. This is a permanent, hybrid position located in Dublin.

Qualifications

• 5+ years in device design and development.
• Hands-on experience with design controls in a GMP environment.
• Strong working knowledge of ISO 13485, ISO 14971, 21 CFR 820 and EU MDR.
• Experience in design verification testing, equipment qualification or statistics is a bonus.

Responsabilités

• Own design assurance for a portfolio of pens, syringes, autoinjectors, patches and inhalers.
• Lead design control and risk management to 21 CFR 820, ISO 13485 and ISO 14971.
• Review and approve design history files across in-house, partnered and acquired programmes.
• Challenge technical decisions and set clear, risk-based paths forward.
• Bring acquired devices and combination products up to standard.
• Support health authority submissions, audits and team training.

Connaissances

Design assurance

Design controls

Risk management

Regulatory compliance

Validation testing

Formation

Engineering or science degree

Description du poste

Valtera Group Ltd. in Dublin, Ireland, is seeking a Senior Design Assurance Engineer/Scientist to own design control for a portfolio of drug delivery devices from planning through approval. The role emphasizes challenging decisions, solving problems and signing off on critical design activities within a GMP environment.

We require 5+ years in device design and development, strong ISO/CFR knowledge, and a collaborative, proactive mindset. This is a permanent, hybrid position located in Dublin.