Senior R&D Product Engineer — Medical Devices (Galway)

ProVerum Ltd.; Galway; Sur place; EUR 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Private health insurance

Company pension scheme

Bonus potential

Résumé du poste

ProVerum Ltd. is seeking a Senior R&D Product Engineer in Galway, Ireland to drive end-to-end device development from concept to scale.

You will work across prototyping, validation, and manufacturing support, reporting to the Senior R&D Manager, in a hands-on, cross-functional team. The role requires a degree in engineering or science and 5+ years in medical devices, with experience in catheter, endoscope or polymer delivery systems, and solid knowledge of ISO 13485 and FDA 21 CFR 820.

Qualifications

• Degree in Engineering or Science with 5+ years in the medical device industry.
• Experience with catheter, rigid/flexible endoscopes and/or polymer delivery systems.
• Experience with product/process validation and design verification/validation.
• Knowledge of medical device materials (nitinol, polymers) and design fundamentals.
• Good knowledge of SolidWorks or comparable CAD.
• Familiarity with ISO 13485 and FDA 21 CFR 820.
• Excellent written and verbal communication skills.
• Project planning and cross-functional execution capability.
• Proactive, roll-up-your-sleeves attitude in a fast-moving environment.

Responsabilités

• Lead R&D projects from concept through regulatory approval, including planning and execution.
• Support Operations to sustain the manufacturing line with real-time troubleshooting and CAPA/NCR investigations.
• Collaborate with Operations and Quality to design and optimise processes and production flow.
• Provide technical support to suppliers to ensure quality and reliability.
• Ensure compliance with QMS and regulatory requirements for PMA and 510(k) products.
• Maintain documentation across DHF, QMS procedures and validation protocols.

Connaissances

Medical device experience

Regulatory knowledge

Mechanical design fundamentals

Communication skills

Project planning

Cross-functional teamwork

Problem solving

Proactive attitude

Formation

Engineering or Science degree

Outils

SolidWorks

Description du poste

ProVerum Ltd. is seeking a Senior R&D Product Engineer in Galway, Ireland to drive end-to-end device development from concept to scale.

You will work across prototyping, validation, and manufacturing support, reporting to the Senior R&D Manager, in a hands-on, cross-functional team. The role requires a degree in engineering or science and 5+ years in medical devices, with experience in catheter, endoscope or polymer delivery systems, and solid knowledge of ISO 13485 and FDA 21 CFR 820.