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.

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The Role

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.

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The Person

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.

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For more information on this opportunity, talk to Laura Gallagher in confidence, email or call her direct line 00 353 91782113.

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