High Salary Senior Design Assurance Engineer
2 weeks ago
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. Education & Training A degree level qualification in Engineering, Science or related field is required. Experience 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. Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on OR Benefits: Bonus, pension, healthcare and hybrid working
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Senior Design Assurance Engineer
2 weeks ago
Galway, Galway, Ireland beBee Careers Full timeSenior Design Assurance Engineer Job Description The role of Senior Design Assurance Engineer is critical to ensuring the quality and safety of medical devices. This position will support sustaining commercial projects from a Design Assurance perspective, directly involved in maintaining products throughout their full lifecycle. Key responsibilities include...
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Senior Design Assurance Engineer
5 days ago
Galway, Galway, Ireland Veryan Medical Full timeJoin to apply for the Senior Design Assurance Engineer role at Veryan MedicalJob OverviewVeryan Medical, a fast-paced and rapidly growing medical device company specializing in vascular interventions, is seeking a Senior Design Assurance Engineer to join our team in Galway. This role offers the opportunity to work on innovative projects aimed at improving...
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Senior Design Assurance Engineer
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Galway, Galway, Ireland TN Ireland Full timeSenior Design Assurance EngineerWe are seeking a Senior Design Assurance Engineer to join our team at Tn-Ireland in Galway, Ireland.About the Role:This is an exciting opportunity for a senior engineer to lead design assurance and quality control efforts within our medical device company. As a Senior Design Assurance Engineer, you will be responsible for...
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Galway, Galway, Ireland CareerWise Recruitment Full timeA SENIOR DESIGN ASSURANCE ENGINEER is required by Career Wise Recruitment for our multinational medical device client in Galway for a hybrid role on an initial 12-month contract.The SENIOR DESIGN ASSURANCE ENGINEER will support sustaining commercial projects from a Design Assurance perspective and be directly involved in making sure the products are...
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Galway, Galway, Ireland Life Science Recruitment Full timeSenior Design Assurance EngineerOur client, a medical device company, is currently seeking a Design Assurance Engineer to join their team.The Design Assurance Engineer will be working in the Quality Assurance/Regulatory Affairs department responsible for Medical Product (CE Mark and FDA 510k) Design Assurance, Design Controls, Product and Process Validation...
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Design Assurance Professional
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Galway, Galway, Ireland beBee Careers Full timeSenior Design Assurance Engineer Job Description The role of Senior Design Assurance Engineer is to ensure the quality and safety of medical devices. This position will support sustaining commercial projects from a Design Assurance perspective, directly involved in maintaining products throughout their full lifecycle. Key responsibilities include assessing...
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Senior Design Assurance Engineer
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Galway, Galway, Ireland STRIVE Search Full time2 days ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.Direct message the job poster from STRIVE SearchQualified Scientist & Principal Recruitment ConsultantHelping professionals find the next step in their career, while fulfilling top client…Senior Design Assurance Engineer - Medical DevicesGalway -...
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Galway, Galway, Ireland Channel Mechanics Full timeOverviewWe are seeking a Senior Quality Assurance Engineer as a key member of our team. We are now building out the QA team to enhance our test efforts and moving to an integrated platform approach. This is an ideal opportunity to be part of a growing team.Key Responsibilities- Work within a cross functional team to understand the product solution.- Design...
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Design Assurance Engineer
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Galway, Galway, Ireland Sigmar Recruitment Full timeDesign Assurance EngineerAbout Your New EmployerJoin a growing start-upmedical device company based in Galway.Be part of a company committed to equal opportunity and cutting-edge medical advancements.About Your New JobLead the Design Review process: Ensure compliance with internal procedures and EU/FDA requirements.Maintain Design History files: Manage...
