This innovative cardiovascular device company using new technology to improve the performance of vascular stents is an exciting and growing organisation based in Galway. They nurture a culture of design and development, challenging conventional thinking, focusing on developing innovative devices for use in peripheral interventional procedures. This organisation is seeking a Design Assurance Manager to lead a development team on projects to introduce or improve products. This role will report directly to the Quality Director and will be a key player in this company's product development and commercialisation strategy. This business is entering into an extremely promising and exciting period in its timeline.
Duties and responsibilities of the Design Assurance Manager will include:
- Lead the development/evolution of the Design Control, Risk Management and associated systems, to encompass new product development technologies.
- Work within the quality system and ensure that the quality policy and company systems and procedures are complied with in line with the Medical Device Directives
- Provide Design Assurance input to R&D project teams for designated projects
- Define design assurance requirements for projects and design changes, including resourcing and timeline planning.
- Understanding the Regulatory requirements for device developments and providing input to projects to encompass these requirements.
- Participate in specification development in relation to design input development. Lead the generation of Design input / Output documents.
You will have skills and experience in the following:
- Degree in Engineering, Science, QA or related discipline.
- 7+ years' experience in the medical device or pharmaceutical industry.
- Familiarity with statistics, validation and physical testing is required.
For more information on this opportunity, talk to Laura Gallagher in confidence, email or call her direct line 00 353 91782113.