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Search Results for Design Assurance
| Job Title. | Location | Salary | Actions |
Senior Design Assurance EngineerRole: Senior Design Assurance Engineer Location: Oranmore, Galway (Hybrid working) Benefits: Excellent salary, pension, healthcare, yearly bonus and share options. Company: My client is a Medical Device company developing highly innovative non-surgical interventions that treat chronic inflammatory Sino-Nasal diseases. They are looking for a Design Assurance Engineer to work play a key role in supporting the lifecycle of our commercially released medical device products. The role involves managing design changes, ensuring continued compliance wit...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Design Assurance EngineerRole: Design Assurance Engineer Location: Oranmore, Galway (Hybrid working) Benefits: Excellent salary, pension, healthcare, yearly bonus and share options. Company: My client is a Medical Device company developing highly innovative non-surgical interventions that treat chronic inflammatory Sino-Nasal diseases. They are looking for a Design Assurance Engineer to work 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 managemen...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Senior Quality Assurance EngineerTitle: Senior Quality Assurance Engineer Location: ATU iHub Galway City. Benefits: Top Salary, share options, hybrid working, flexitime and bonus Company: My client a clinical-stage CE Marked and FDA approved medical device manufacturer. Currently seeking an innovative Quality Assurance professional. The successful candidate will be an active member of the QA/RA team building innovative minimally invasive devices designed specifically for sufferers of chronic venous disease. Product: My clients first product is a mechanical endovenous infusion...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Senior Quality EngineerTitle: Senior Quality Engineer Location: ATU iHub Galway City. Benefits: Top Salary, share options, hybrid working, flexitime and bonus Company: My client a clinical-stage CE Marked and FDA approved medical device manufacturer. Currently seeking an innovative Quality Assurance professional. The successful candidate will be an active member of the QA/RA team building innovative minimally invasive devices designed specifically for sufferers of chronic venous disease. Product: My clients first product is a mechanical endovenous infusion catheter ...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Senior Quality Assurance EngineerTitle: Senior Quality Assurance Engineer Location: ATU iHub Galway City. Benefits: Top Salary, share options, hybrid working, flexitime and bonus Company: My client a clinical-stage CE Marked and FDA approved medical device manufacturer. Currently seeking an innovative Quality Assurance professional. The successful candidate will be an active member of the QA/RA team building innovative minimally invasive devices designed specifically for sufferers of chronic venous disease. Product: My clients first product is a mechanical endovenous infusion...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Quality ManagerJob title: Quality Manager Location: Galway Benefits: Top salary, Bonus, pension, healthcare and hybrid. Company: My client are a Medical device manufacturer with a new hub in Galway. They specialise in catheters, medical balloons, EM-Micro Sensors, engineered shafts, and complete device assemblies, supporting a wide range of interventional therapies. Responsibilities: Act as the Management Representative for the Quality Management System (QMS). Ensure the QMS processes and documentation are established, implemented, ...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Design Assurance EngineerRole: Design Assurance Engineer Location: Oranmore, Galway (Hybrid working) Benefits: Excellent salary, pension, healthcare, yearly bonus and share options. Company: My client is a Medical Device company developing highly innovative non-surgical interventions that treat chronic inflammatory Sino-Nasal diseases. They are looking for a Design Assurance Engineer to work 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 managemen...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Quality ManagerTitle: QA / RA Manager Location: ATU Ihub, Dublin Road, Galway Company: My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body. Role: QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influe...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Quality ManagerTitle: QA / RA Manager Location: ATU Ihub, Dublin Road, Galway Company: My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body. Role: QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influe...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Quality ManagerTitle: QA / RA Manager Location: ATU Ihub, Dublin Road, Galway Company: My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body. Role: QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influe...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Principal Design Assurance EngineerJob title: Principal Design Assurance Engineer Location: Parkmore Business Park, Galway. Benefits: Excellent salary, bonus, pension, healthcare, opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are an early stage Irish MedTech company located in Galway, a global centre for excellence in medical technologies. The company collaborates with clinicians and research institutions across the world developing and commercialising a new technology platform for endovascular surgery that wi...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Design Assurance ManagerDesign Assurance Manager This is a rare opportunity to step into a high-impact Design Assurance leadership role within a scaling medical device company where your work will directly influence the safety, performance, and success of innovative products reaching patients globally. If you thrive at the intersection of engineering, quality, and regulatory strategy, and want to play a pivotal role in a fast-moving, entrepreneurial environment — this is the role that puts you at the centre of it all. We are working with a growing, innovation-driven medical dev...Location: Galway, |
Galway | Not Disclosed | |
Senior Design Assurance EngineerJob title: Senior Design Assurance Engineer Location: Parkmore Business Park, Galway. Benefits: Excellent salary, bonus, pension, healthcare, hybrid working and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are an early stage Irish MedTech company located in Galway, a global centre for excellence in medical technologies. The company collaborates with clinicians and research institutions across the world developing and commercialising a new technology platform for endovascular...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Senior Design Assurance EngineerJob title: Senior Design Assurance Engineer Location: Parkmore Business Park, Galway. Benefits: Excellent salary, bonus, pension, healthcare, hybrid working and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are an early stage Irish MedTech company located in Galway, a global centre for excellence in medical technologies. The company collaborates with clinicians and research institutions across the world developing and commercialising a new technology platform for endovascular...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Design Quality EngineerRole: Design Assurance Engineer Location: Oranmore, Galway Benefits: Excellent salary, pension, healthcare and yearly bonus Company: My client is a Medical Device company developing highly innovative non-surgical interventions that treat chronic inflammatory Sino-Nasal diseases. They are looking for 2 Design Assurance Engineers to work on a Product development stage Next Gen device - currently in concept phase plan to move into design & development Feb/March 2023. Also an Existing device – commercially released but iterative chan...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Design Assurance EngineerRole: Design Assurance Engineer Location: Oranmore, Galway Benefits: Excellent salary, pension, healthcare, yearly bonus and share options. Opportunity to expand your experience in an exciting company in the Medical Device industry going through huge growth. Company: My client is a Medical Device company developing highly innovative non-surgical interventions that treat chronic inflammatory Sino-Nasal diseases. They are looking for a Design Assurance Engineer to work play a key role in supporting the lifecycle of our commercially released medical dev...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Design Assurance EngineerRole: Design Assurance Engineer Location: Oranmore, Galway (Hybrid working) Benefits: Excellent salary, pension, healthcare, yearly bonus and share options. Company: My client is a Medical Device company developing highly innovative non-surgical interventions that treat chronic inflammatory Sino-Nasal diseases. They are looking for a Design Assurance Engineer to work 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 managemen...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Design Assurance Program ManagerJob title: Design Assurance Program Manager Location: Ballybrit Upper Industrial Estate, Galway Benefits: Hourly rate contract, 3 days a week (Partime), Hybrid working Company: My client are a global leader in the medical device industry and expert in the design, development, and manufacturing of complex medical devices and component technologies. Responsibilities: • Lead Quality Representative on projects, directly contributing and/or providing guidance to others to establish appropriate Design History File / Device Master Record docume...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Quality SpecialistJob title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m...Location: Clare, Limerick, Limerick City, Republic of Ireland, |
EU | Not Disclosed | |
Quality SpecialistJob title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m...Location: Clare, Limerick, Limerick City, Republic of Ireland, |
EU | Not Disclosed | |
Quality SpecialistJob title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m...Location: Clare, Limerick, Limerick City, Republic of Ireland, |
EU | Not Disclosed | |
Quality EngineerRole: Quality Engineer Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension, healthcare and hybrid working Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Assist with the implementation and development of the site QMS in line with the ...Location: Athlone, Connaught, Leitrim, Longford, Midlands, |
EU | Not Disclosed | |
QA EngineerRole: QA Engineer (Validation) Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension and healthcare Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Ensuring that product introductions & change controls are effectively managed...Location: Leitrim, Longford, Midlands, Roscommon, |
EU | Not Disclosed | |
Senior Design Assurance EngineerSenior Design Assurance Engineer Our client a Galway based Medical Device company currently seeks a Senior Design Assurance Engineer. Reporting to the Design Assurance Manager the successful candidate will be focused on the development of new technologies Role/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 Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality...Location: Galway, |
Galway | Not Disclosed |
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Design Assurance Career Profile
Design Assurance
Design Assurance engineers provide quality support to R&D and assist in the scale up and commercialization of product.
Role/Responsibility
- Support risk management activities
- Evaluation of new products, assuring the safety and efficacy of the devices
- Design verification and shelf life protocols / reports
- Qualification and validation activities
- Knowledge of regulatory compliance requirements for product design, development, transfer and commercialization activities
- Adhere to Quality System and Design Control requirements
- Root cause investigations; drive problem solving efforts for quality issues
- Manage the compilation of design verification and shelf life data for regulatory submissions to support product approval and release
- Clearly present information to Regulatory Affairs to minimize Regulatory Agency questions
- Support customer complaint analysis and post market surveillance activities
- Generate and approve change requests
Skill/Experience
- Bachelor's Degree in Engineering or Science related Discipline (Master's Degree desirable)
- A minimum of 2 years experience, with at least 1 years experience in the Medical Device industry
- A minimum of 1 years experience in product & process development