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Senior Design Assurance Engineer
| Reference: | JCAO2412 | Location: |
Dublin |
| Qualification: | Degree | Experience: | 5-7 Years |
| Job Type: | Permanent | Salary: | Not Disclosed |
Our client a high potential start-up are currently seeking a Senior Design Assurance Engineer to join their team. Reporting to the CTO the Senior Design Assurance will work with the core development team on a second generation delivery system. The Senior Design Assurance will join the team in the advancement of a nitinol implant with first and second generation delivery systems from design, manufacture, verification/validation testing, clinical trial and regulatory approval. Senior Design Assurance will 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.
Role/Responsibilities
• Core part of the engineering team working on product design, development and testing of a novel device, from concept stage through to regulatory approval
• Work closely with clinicians, quality, regulatory and clinical to develop test programmes and test methods
• Liaise and support vendors during the prototyping and manufacture of device components, test fixtures and tooling
• Core participation in advancement from concept/prototype to manufacturing process development with a focus on development for successful device assembly and design verification testing and clinical use i.e. analysing, reducing and managing risks associated with the design, use, and manufacture of medical devices
• Conduct design verification bench testing of the device and device components
• Draft and compile technical documentation to support product development in accordance with the Medical Device Directive (MDD) and ISO 13485 Quality Management System
• Participate in the generation and maintenance of product Risk Management Files.
Skills and Experience:
• The successful candidate should be degree qualified in a relevant Engineering or Science discipline
• 4-5 years’ experience in medical device industry in a related role
• Project planning skills
• Excellent communication and writing skills
• Excellent mechanical design and understanding of engineering fundamentals with medical device materials knowledge, medical device polymers and nitinol behaviour
• Experience in medical device testing for regulatory compliance, risk management, design control in line with quality system requirements
• Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820)
For further information please contact James Cassidy [email protected] or call 0860204322
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