Senior Design Assurance Engineer
8 hours ago
At 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 solve problems, make progress, and deliver meaningful innovations.Our PurposeWithin our Structural Heart Design Assurance Group in Medtronic, plc, we focus on providing Quality support across all aspects of PDP from pre market product development to post market product surveillance.We participate in the design process to ensure the performance and safety of the Structural Heart devices we develop, is assured and maintained throughout the product lifecycle.Come for a job, stay for a careerA Day in The Life Of:You will serve as extended team member on a PDP Project representing the Design Assurance function and will report dotted line to the quality lead on the project.You will lead strategies for risk management, test method validations, design verification and shelf-life protocols / reports.You will be responsible for keeping abreast of industry best practice with respect to product design.You will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer and commercialisation activities.You will be required to liaise with departments, both internally and externally to build strong collaborative partnerships.You will be required to provide Quality input into new product development, process improvements and change control.As required, you will support cross functional teams to design protocols to ensure that new products/ product changes are adequately evaluated/tested with respect to standard requirements.Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.Key Skills & Experience- Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.- Requires a minimum Level 8 degree in Engineering or other relevant discipline with minimum 4 years' relevant experience.- Experience in a highly regulated industry, preferably medical devices.- You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams.- You are experienced to a competent level within Medical Device product design.- Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions are a must.- Excellent communication and ability to influence is critical to the role.Flexibility to travel
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Senior Design Assurance Engineer
8 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
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
8 hours ago
Galway, Ireland Versono Medical Ltd Full timePosition:Senior Design Assurance EngineerThe role of Senior Design Assurance Engineer is to be the QA technical and compliance expert as part of a cross functional team for the design and development of sterile and non sterile medical devices and /or subsequent modifications thereafter in compliance to current Regulatory requirements i.e. ISO *****, CFR 820...
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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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Design Assurance Engineer
8 hours ago
Galway, Ireland Allegis Group Full timeJoin 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),...
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Principal Design Assurance Engineer
9 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 Medtronic Full timeSenior Design Assurance Engineer - 12 month FTC At 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. Overview In the Coronary/RDN Post Market Design Assurance...
