SUMMARY

Veryan Medical is a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. We share a commitment, a passion, and a vision for the contribution Veryan makes to innovation in interventional medicine.
Our team powers Veryan’s business. Whether sales representatives, design engineers, quality engineers, or clinical study managers, our people bring an unmatched expertise in each of their fields that both inspires and challenges.
Veryan’s culture of innovation helps each individual develop both professionally and personally, and our culture of respect means that we all work in a collaborative, empowering, and exciting environment. We are committed to excellence through our patient-centric approach, and we pride ourselves in our integrity of doing what is right and doing what we say.
Reporting to the Director of Design Assurance, the Design Assurance Engineer will collaborate with the development teams to enhance Veryan’s new product portfolio, working predominantly on projects aimed at introducing or improving products for the treatment of a range of peripheral arterial diseases states. This is a fantastic opportunity, which will allow the successful candidate to work as part of a supportive, collaborative team in our state-of-the-art facility here in Parkmore, Galway.

EDUCATION

• Bachelor’s degree in Engineering, Science or related field is required.

EXPERIENCE

• A minimum of three years’ relevent experience in the medical device industry.
• Familiarity of ISO13485, ISO14971 and FDA QSRs is required.
• Familiarity with risk management, statistics, validation and physical testing is required.
• Good communication and organisational skills, and the ability to present reports neatly and accurately is essential.

• Work within the quality system and ensuring that the quality policy and company systems and procedures are complied with in line with the Medical Device Regulation 2017/745 , Medical Device Directive 93/42/EEC, FDA Quality System Regulations 21 CFR Part 820, FDA GLP Regulation 21 CFR 58, ISO 13485, ISO 14971, Japanese Ministerial Ordinance # 169.
• Support the development / evolution of the Veryan Design Control, Risk Management and associated systems, to encompass new product development technologies.
• Provide Design Assurance input to R&D project teams for designated projects.
• 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. Participate in the generation of Design Input / Output documents.
• Support the risk management activities for designated projects and design changes.
• Design, development and validation of test methods as required to support development programs.
• Develop and maintain design verification and validation plans, protocols and reports.
• Support R&D in the preparation and delivery of Design Reviews and associated checklists.
• Support the conduct of non-clinical studies at third party facilities in conjunction with R&D department.
• Establish and maintain the Design History File and associated documents.
• Provide QA support to R&D for equipment management.
• Execute assigned aspects of the project, as required.