Principal R&D Medical Device Engineer - Galway Leader

ProVerum Ltd.; Galway; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Leadership

Project planning

Regulatory knowledge

Medical device

Hands-on engineering

Formation

Engineering/Science degree

Description du poste

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.