Design Assurance Engineer
14 hours ago
Join a dynamic product development team driving the creation of a cutting-edge, software-driven medical device console.As the Design Assurance Engineer, you'll play a pivotal role in embedding safety, quality, and compliance into every stage of the product lifecycle.This position demands strong expertise in IEC software lifecycle), IEC electrical safety), ISO *****, ISO *****, and ISO *****, with a focus on ensuring regulatory readiness and robust design controls.You'll collaborate closely with cross-functional teams—especially R&D—to guide verification and validation (V&V) activities, risk management, and documentation that support global regulatory submissions and successful commercialisation.Your contributions will directly impact patient safety and product performance.Key Responsibilities:Ensure compliance with FDA 21 CFR and international standards including ISO *****, ISO *****, IEC *****, IEC *****, and ISO *****.Partner with engineering teams to implement design controls, risk management strategies, and V&V protocols aligned with regulatory expectations.Develop and validate test methods for hardware and software systems, ensuring traceability from requirements through testing.Lead and support design reviews, maintain the Design History File (DHF), and ensure documentation integrity.Stay current with evolving regulatory requirements and contribute to continuous improvement of design assurance processes.Provide technical expertise during audits and regulatory submissions, and mentor team members on best practices in embedded systems, usability engineering, and cybersecurity.This is a unique opportunity to influence the development of a high-impact medical device, working in a fast-paced, mission-driven environment focused on innovation and improving patient outcomes.
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Design Assurance Engineer
3 weeks ago
Galway, Ireland AMA Consulting Group LLC Full timeNeurent Medical is seeking a highly motivated and experienced Design Assurance Engineer to join our team. This individual will play a key role in supporting the lifecycle of our commercially released medical device products. The role involves managing design changes, ensuring continued compliance with risk management and design control requirements, and...
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Design Assurance Engineer
2 weeks ago
Galway, Ireland Ama Consulting Group Llc Full timeNeurent Medical is seeking a highly motivated and experienced Design Assurance Engineer to join our team.This individual will play a key role in supporting the lifecycle of our commercially released medical device products.The role involves managing design changes, ensuring continued compliance with risk management and design control requirements, and...
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Senior Design Assurance Engineer
14 hours ago
Galway, Ireland Barrington James Full timePosition: Senior Design Assurance EngineerWe are partnering with a growing medical device company to appoint a Senior Design Assurance Engineer in Galway.This role will give you the chance to take ownership of QA activities across the full product lifecycle, from design and development through to commercialisation.Key Responsibilities• Lead risk...
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Senior Design Assurance Engineer
2 weeks ago
Galway, Ireland Barrington James Full timeOverview We are partnering with a growing medical device company to appoint a Senior Design Assurance Engineer in Galway. This role will give you the chance to take ownership of QA activities across the full product lifecycle, from design and development through to commercialisation. Responsibilities Lead risk assessments, design verification/validation,...
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Senior Design Assurance Engineer
4 weeks ago
Galway, Ireland Barrington James Full timeOverviewWe are partnering with a growing medical device company to appoint a Senior Design Assurance Engineer in Galway.This role will give you the chance to take ownership of QA activities across the full product lifecycle, from design and development through to commercialisation.ResponsibilitiesLead risk assessments, design verification/validation, and DHF...
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Senior Design Assurance Engineer
4 weeks ago
Galway, Ireland Medtronic Full timeOverviewAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.Within our Structural Heart Design Assurance Group in Medtronic, plc, we focus on providing Quality support...
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Principal Design Assurance Engineer
14 hours ago
Galway, Ireland Scipro Full timePrincipal Design Assurance EngineerWe are seeking an experienced and motivatedPrincipal Design Assurance Engineer(seniority dependent on background) to take a leading role in scaling our operations.This hybrid position will support manufacturing, facilities, and supply chain functions as the organisation moves from development into commercial launch.This...
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Senior Design Assurance Engineer
3 weeks ago
Galway, Ireland Wallace Myers International Full timePosition: Senior Design Assurance EngineerThe Senior Design Assurance Engineer will act as the QA technical and compliance expert within a cross-functional team, supporting the design and development of sterile and non-sterile medical devices, as well as subsequent modifications, in line with regulatory requirements (ISO 13485, 21 CFR 820/QMSR, and other...
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Senior Design Assurance Engineer
13 hours ago
Galway, Ireland Medtronic Full timeAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeMedtronicAt Medtronic, we value what makes you unique.Be part of a company that thinks differently to...
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Principal Design Assurance Engineer
14 hours ago
Galway, Ireland Medtronic Full timeAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeMedtronicAt Medtronic, we value what makes you unique.Be part of a company that thinks differently to...
