Senior Quality Design Engineer – Medical Devices

Boston Scientific; Galway; In loco; EUR 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

Boston Scientific is seeking a Senior Quality Design Engineer to join the Design Assurance team in Ireland. You will lead cross-functional NPD initiatives, shape design strategy, and drive risk management to ensure patient safety and product excellence.

You will develop verification and validation protocols, maintain Design History Files, and lead change control while collaborating with R&D, regulatory, and manufacturing teams to deliver high-quality medical devices worldwide.

Competenze

• BSc in Engineering or related technical field.
• 7+ years in quality engineering or design assurance in medical devices.
• Knowledge of ISO 13485 and ISO 14971.
• Proven cross-functional leadership and influence.

Mansioni

• Lead senior-level quality engineering on cross-functional NPD teams.
• Ensure robust design inputs, verification and validation plans.
• Drive risk management activities per ISO 14971.
• Develop and approve DHF documentation and design outputs.
• Lead design change control and assess product/process impacts.
• Monitor field performance and drive CAPAs as needed.
• Mentor junior engineers and share best practices.

Conoscenze

Problem solving

Quality leadership

Cross-functional collaboration

Statistical methods

Risk management

Regulatory compliance

Communication skills

Formazione

BSc in Engineering

Descrizione del lavoro

Boston Scientific is seeking a Senior Quality Design Engineer to join the Design Assurance team in Ireland. You will lead cross-functional NPD initiatives, shape design strategy, and drive risk management to ensure patient safety and product excellence.

You will develop verification and validation protocols, maintain Design History Files, and lead change control while collaborating with R&D, regulatory, and manufacturing teams to deliver high-quality medical devices worldwide.