Senior Design Assurance Engineer — Drug Delivery Devices

Valtera Group Ltd; Dublin; On-site; EUR 75,000 - 105,000; Full time

Job summary

Valtera Group Ltd seeks a Senior Design Assurance Engineer to own design control for its drug delivery device portfolio from planning through approval. You will challenge decisions, sign off VA files and drive in-house verification testing within a GMP environment.

You'll lead risk management to 21 CFR 820, ISO 13485 and ISO 14971, review DHFs across programmes, and support health authority submissions and audits. This role is based in Dublin, Ireland with collaboration across global teams.

Qualifications

• An engineering or science degree.
• 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.
• Resilient, independent and collaborative: you call out problems and help fix them.

Responsibilities

• 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.

Skills

Device design knowledge

GMP experience

Regulatory compliance

Risk management

Problem solving

Education

Engineering or science degree

Job description

Valtera Group Ltd seeks a Senior Design Assurance Engineer to own design control for its drug delivery device portfolio from planning through approval. You will challenge decisions, sign off VA files and drive in-house verification testing within a GMP environment.

You'll lead risk management to 21 CFR 820, ISO 13485 and ISO 14971, review DHFs across programmes, and support health authority submissions and audits. This role is based in Dublin, Ireland with collaboration across global teams.