Job title: Senior Design Assurance Engineer
Location: Parkmore Business Park, Galway (Hybrid working 2 days a week on site)
Benefits: Competitive salary, 10% bonus, Hybrid working, Full family healthcare, flexible working hours and pension contribution. Also an excellent opportunity to build your career with an exciting Medical Device company going through a growth phase.


Company:
My client are a rapidly growing medical device company offering a highly differentiated solution in SFA interventions. Their culture of innovation helps each individual develop both professionally and personally, their culture of respect means that they all work in a collaborative, empowering, and exciting environment.


Role:
Reporting to the Design Assurance Director, the Senior Design Assurance Engineer will work as part of the team in supporting the sustainment commercialised stent platforms and in the development of the new stent platforms, where they will focus predominantly on projects to introduce or improve products for the treatment of peripheral arterial disease states. This is a fantastic opportunity which will allow the successful candidate to work as part of a supportive, collaborative team in the new state-of-the-art facility here in Galway.



Job Requirements

• Work within the quality system to ensure that the quality policy and company systems and procedures are complied with in line with the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, MDR 2002 (UK), FDA Quality System Regulations 21 CFR § 820, FDA GLP Regulation 21 CFR § 58, FDA Labelling Regulation 21 CFR § 801, ISO 13485, ISO 14971 and 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.
• Lead the risk management activities for assigned projects in line with ISO 14971 and Veryan procedures.
• Develop and maintain design verification and validation plans, protocols, and reports for design changes.
• Support the preparation and delivery of Design Transfer to Commercial Reviews and associated checklists.
• Design, development and validation of test methods as required to support development programs.
• Lead Human Factors / Usability Engineering activities and maintain Usability Engineering File for assigned projects.
• (Where applicable) Support the execution of non-clinical studies at third party facilities, in conjunction with R&D department.
• 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.

• A degree level qualification in Engineering, Science or related field is required.

• Upwards of 4 years’ relevant 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.
• Familiarity with statistics, validation and physical testing is required.