Principal R&D Product Engineer

ProVerum; Galway; On-site; EUR 90,000 - 120,000; Full time

Job summary

ProVerum Ltd. is seeking a Principal R&D Product Engineer to lead the design, development, manufacture and testing of a novel medical device, from concept through to regulatory approval, in Galway, Ireland.

You will provide technical leadership to the R&D team, collaborate with Quality, Regulatory and Operations, and work with vendors to bring endoscopes, catheters and delivery systems to production in a fast-moving environment.

Qualifications

• Degree in Engineering or Science, 8–10 years in the medical device industry.
• Experience in endoscopes, catheters, moulding/micro-moulding and/or polymer and metal-based delivery systems.
• Demonstrated leadership experience managing R&D projects, with strong project planning skills.
• Knowledge of medical device quality and regulatory requirements, including ISO 13485.
• Excellent written, interpersonal and presentation skills.
• A self-starter with a positive, 'roll-up-your-sleeves' attitude suited to a fast-moving environment.

Responsibilities

• Lead the design, development, manufacture and testing of a novel device, from concept through to regulatory approval.
• Provide technical leadership to the R&D team, promoting innovation and high engineering standards.
• Support vendors from early development through to production of endoscopes, catheters and delivery systems.
• Support Operations in sustaining the manufacturing line through real-time troubleshooting, and CAPA and NCR investigations.
• Advise Operations and Quality on optimising manufacturing processes and production flow.
• Work with Quality and Regulatory to ensure the device meets user, regulatory and ISO 13485 requirements.
• Support KOL relationships with technical demonstrations and data, and contribute to innovation and IP filing.

Skills

Leadership

Project planning

Regulatory knowledge

Medical device

Hands-on engineering

Education

Engineering/Science degree

Job description

Principal 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 Principal R&D Product Engineer to join our core development team and advance the design, development, manufacture and testing of our medical devices. You'll prototype designs, develop final design specifications based on user needs, and support manufacturing process development with key vendors.

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 leading the development of a novel medical device from concept to regulatory approval, 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 alongside Quality, Regulatory and Operations. You'll thrive in a small, fast-paced environment where flexibility is 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 8–10 years' experience in the medical device industry

• Experience in endoscopes, catheters, moulding/micro-moulding and/or polymer and metal-based delivery systems

• Demonstrated leadership experience managing R&D projects, with strong project planning skills

• Knowledge of medical device quality and regulatory requirements, including ISO 13485

• Excellent written, interpersonal and presentation skills

• A self-starter with a positive, 'roll-up-your-sleeves' attitude suited to a fast-moving environment

In this role you will:

• Lead the design, development, manufacture and testing of a novel device, from concept through to regulatory approval

• Provide technical leadership to the R&D team, promoting innovation and high engineering standards

• Support vendors from early development through to production of endoscopes, catheters and delivery systems

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

• Advise Operations and Quality on optimising manufacturing processes and production flow

• Work with Quality and Regulatory to ensure the device meets user, regulatory and ISO 13485 requirements

• Support KOL relationships with technical demonstrations and data, and contribute to innovation and IP filing