Senior R&D Medical Device Engineer: From Prototype to Scale-Up

ProVerum Ltd.; Galway; On-site; EUR 85,000 - 120,000; Full time

Benefits offered by this job

Private health insurance

Company pension

Bonus potential

Job summary

ProVerum in Galway is seeking a Senior R&D Product Engineer to join the R&D team. You will own projects from concept through to commercial scale, collaborating across engineering, operations, and quality to deliver safe and effective devices for BPH treatment.

The role emphasizes hands-on development, prototype-to-scale work, and cross-functional teamwork in a small, entrepreneurial environment with a patient-focused mission.

Qualifications

• Minimum 5 years in the medical device industry.
• Exposure to manufacturing processes for catheters, endoscopes, or delivery systems.
• Experience in product/process validation and design verification/validation.
• Good mechanical design skills and knowledge of device materials.
• Knowledge of ISO 13485 and FDA 21 CFR 820 is advantageous.
• Excellent communication and technical writing skills.
• Project planning and execution skills.

Responsibilities

• Support and lead R&D projects from concept through to regulatory approval, including planning and execution.
• Support Operations in sustaining the manufacturing line with real-time troubleshooting during builds and investigations.
• Partner with Operations and Quality to design and optimise manufacturing processes, procedures and production flow.
• Provide technical support to suppliers to ensure supply reliability and product quality.
• Ensure all products and changes comply with QMS and regulatory requirements for PMA and 510(k).
• Maintain documentation across production records, DHF, QMS procedures and validation reports.
• Compile documentation for EU MDR and ISO 13485 including document control and test reports.

Skills

Medical devices

CAD SolidWorks

Regulatory knowledge

Education

Engineering degree

Tools

SolidWorks

Job description

ProVerum in Galway is seeking a Senior R&D Product Engineer to join the R&D team. You will own projects from concept through to commercial scale, collaborating across engineering, operations, and quality to deliver safe and effective devices for BPH treatment.

The role emphasizes hands-on development, prototype-to-scale work, and cross-functional teamwork in a small, entrepreneurial environment with a patient-focused mission.