Principal Medical Device R&D Engineer (Endoscopy)

ProVerum Ltd.; Galway; On-site; EUR 90,000 - 130,000; Full time

Job summary

ProVerum Ltd. is seeking a Principal R&D Product Engineer in Galway, Ireland, to lead the design, development, manufacture and testing of a novel medical device. You will prototype, define final specs from user needs, and support manufacturing process development with key vendors.

You will report to the Senior R&D Manager and work across Quality, Regulatory and Operations in a fast-paced environment. Strong hands-on delivery and leadership are essential.

Qualifications

• 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 planning skills.
• Knowledge of medical device quality and regulatory requirements, including ISO 13485.
• Excellent written, interpersonal and presentation skills.

Responsibilities

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

Skills

Leadership

Project planning

Regulatory knowledge

Quality systems

Written & presentation skills

Education

Engineering or Science degree

Tools

ISO 13485

Job description

ProVerum Ltd. is seeking a Principal R&D Product Engineer in Galway, Ireland, to lead the design, development, manufacture and testing of a novel medical device. You will prototype, define final specs from user needs, and support manufacturing process development with key vendors.

You will report to the Senior R&D Manager and work across Quality, Regulatory and Operations in a fast-paced environment. Strong hands-on delivery and leadership are essential.