Design Assurance Engineer

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

Senior Design Assurance Engineer / Scientist

Owning design control for drug delivery devices, concept to approval

Medical Devices and Combination Products

A global pharmaceutical company is strengthening design assurance within its device development function. You will sit within project teams and own design control for a portfolio of drug delivery devices, from planning through approval. You will be expected to challenge, solve problems and sign off decisions, not just review them, while helping the team bring design verification testing in-house.

What You Will Do

• 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.

What We’re Looking For

• An engineering or science degree, with a strong sense of how devices are designed and made.
• 5+ years in device design and development, ideally with a strong device-design background.
• 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.