Senior Design Assurance Engineer

Senior Design Assurance Engineer

Full time- Permanent

Galway- Hybrid

We have an exciting opportunity for a Senior Design Assurance Engineer to join Veryan Medical!

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 Senior 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.

Job Requirements

Main Responsibilities

• 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 Directive93/42/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 (e.g., labelling/packaging).
• Provide Design Assurance input to R&D project teams for designated projects.
• Support sustaining activities with a specific focus on design changes to meet business needs in line with updated standards and regulatory requirements and assess product impact with integration into QMS as required.
• Understand the Regulatory requirements for device developments and provide input to projects to encompass these requirements.
• Lead in specification development in relation to design input development.
• Participate in the generation of Design Input /Output documents.
• Lead the risk management activities for designated projects and design changes.
• Lead Human Factors / Usability Engineering activities and maintain Usability Engineering File for all products.
• 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 DA support to R&D for equipment management and validation.
• Manage the labelling and packaging requirements of new and commercial products identifying upcoming changes to labelling and co-ordinate with R&D for timely implementation.
• Execute/ review gap analysis to standards, ASTMs and other associated documents and assess impact to product DHFs.
• Coaching and mentoring of colleagues and more junior members of the team.

Education

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

Experience

• A minimum of five years’ relevent experience in the medical device industry preferably with Stent or class III device design assurance experience.
• An understanding of ISO 13485, ISO 14971 and FDA QSRs is a prerequisite.
• Experience with risk management, statistics, validation and physical testing is required.
  
• Excellent communication, organisational skills and the ability to present reports neatly and accurately is essential.

Benefits of Working with Veryan

• Competitive salary and bonus.
• Pension scheme with generous employer contributions.
• Private medical insurance for you, spouse / partner and dependents.
• Paid sick leave.
• Group life cover.
• Annual leave of 23 days plus bank holidays increasing to 24 days after two years’ service and 25 days after five years’ service.
• Active Sports and Social Committee with a schedule of events taking place during the year.
• Hybrid working.
• Flexible start and finish times.
• Opportunities for further education, training and development.

Company Values

• Collaborative
• Innovative
• Empowering
• Patient-centric
• Acting with Integrity

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