Medical Engineers have been engaged by a medical device development company based in Ireland who have a requirement for a Senior Design Assurance engineer with experience in the design and development of implantable products made using NiTinol.
Our clients innovative minimally invasive technology will treat symptomatic benign prostatic hyperplasia (BPH) which affects c50% of men over the age of 50.
Based in their Dublin facility, this senior engineer position will lead the advancement of the nitinol implant and second-generation delivery system from design, manufacture, verification/validation, clinical trial, and regulatory approval.
The candidate will work with quality and regulatory teams to ensure the device meets user, regulatory and ISO 13485 requirements. Candidates should have a hands-on approach to projects with a motivated attitude and strong work ethic. An ability to work and adapt in a flexible and fast-paced environment is essential.
Responsibilities and Contribution:
* Core part of the engineering team working on product design and development from concept stage through to regulatory approval
* Liaise and support vendors during the prototyping and early stage manufacture of device components
* Finite element analysis of device components
* Test method design
* Conduct bench testing of the device and device components
* Core participation in advancement from concept/prototype to manufacturing process development, device assembly and design verification testing and clinical
* Draft and compile technical documentation to support product development in accordance with the Medical Device Directive (MDD) and their ISO 13485 Quality Management System
Skills and Experience Required:
* Bachelor’s degree in a biomedical, mechanical or materials Engineering discipline with a higher level postgraduate degree (masters or PhD) related to Nitinol and mechanical testing with 2+ years industry experience in a related role, or 5+ years industry experience in a related R&D role
* Experience of Nitinol material processing and technical specifications essential
* Knowledge of FEA essential
* Test method development experience essential
* Sound understanding of mechanical design and engineering fundamentals
* Strong communication and writing skills
* Materials knowledge of medical device polymers an advantage
* Good working knowledge of Solidworks or other CAD package an advantage
* Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820) an advantage
Medical Device Directive
Iso 13485 Standard
Solid Works (Cad)
Finite Element Methods