Senior R&D Product Engineer

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

Senior R&D Product Engineer

Location: Galway, Ireland | Full-Time, On-site | Reports to: Senior R&D Manager

ProVerum is transforming the treatment of Benign Prostatic Hyperplasia (BPH) with minimally invasive technology redefining the standard of care. As we scale, we're looking for a Senior R&D Product Engineer to join our R&D team in Galway.

Why ProVerum?

You'll have real ownership, visible impact, and the opportunity to shape the future of BPH treatment, working alongside a team that cares deeply about the patients at the end of every decision.

Why you’ll Thrive?

You're energised by owning a project from the first prototype through to commercial scale-up, and you're happiest when you're hands-on. Reporting to the Senior R&D Manager, you'll work across every stage of device development: prototyping, final manufacture, clinical investigation, commercialisation and scale-up. You'll thrive in a small, entrepreneurial environment where flexibility and cross-functional teamwork are the norm, and where a good attitude and strong work ethic count for as much as your technical skills.

You’ll likely have:

• A degree in a relevant Engineering or Science discipline, with a minimum of 5 years' experience in the medical device industry

• Exposure to manufacturing processes for catheters, rigid/flexible endoscopes and/or polymer-based delivery systems

• Experience in product/process validation and design verification/validation

• Good mechanical design skills and engineering fundamentals, with strong knowledge of medical device materials (metallic introducers, nitinol and medical device polymers a strong advantage)

• Good working knowledge of SolidWorks or a comparable CAD package

• Knowledge of medical device quality and regulatory systems, including ISO 13485 and FDA 21 CFR 820 (a distinct advantage)

• Excellent communication and technical writing skills

• Project planning and execution skills (an advantage)

• A proactive, 'roll-up-your-sleeves' attitude suited to a fast-moving, cross-functional environment

In this role you will:

• Support and lead R&D projects from concept through to regulatory approval, including project planning and execution

• Support Operations in sustaining the manufacturing line through real-time troubleshooting during builds, and CAPA and NCR investigations

• Partner with Operations and Quality to design and optimise manufacturing processes, procedures and production flow

• Provide technical support to suppliers of components and sub-assemblies to ensure supply reliability, product quality and process consistency

• Ensure all products, processes and changes comply with QMS and regulatory requirements for PMA and 510(k) products

• Maintain documentation across production records, DHF, QMS procedures and validation protocols and reports

• Compile documentation to support sustaining and development activities in line with EU MDR and ISO 13485, including document control and writing protocols and test reports

Why Join the ProVerum Team?

Visible impact from day one:Your work directly supports the devices that reach patients

Build something lasting:Join at a formative stage and help shape the technical foundations of a company

Collaborative culture:Work alongside passionate engineers, technicians, and operators who care deeply about product quality and patient outcomes

Location:Galway's vibrant medtech ecosystem in Ballybrit

Competitive package:Market salary, bonus potential, company pension scheme, private health insurance and more