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Search Results for Design Assurance
Job Title. Location Salary Actions

Senior Quality Engineer

Job title: Senior Quality Engineer Location: Glasnevin, Dublin 11 (on site role) Benefits: Top salary, Bonus, pension and Healthcare Company: My client are currently running clinical trials across Europe and the US, in collaboration with leading researchers and scientists who share our commitment to transforming the lives of the millions of people living with heart failure. They have a diverse team who respect each other’s opinions and work and learn together in an open and honest way to achieve their ambitious purpose. Job Overview: To driv...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Quality Engineer 		EU Not Disclosed

Senior Quality Engineer

Job title: Senior Quality Engineer Location: Glasnevin, Dublin 11 (on site role) Benefits: Top salary, Bonus, pension and Healthcare Company: My client are currently running clinical trials across Europe and the US, in collaboration with leading researchers and scientists who share our commitment to transforming the lives of the millions of people living with heart failure. They have a diverse team who respect each other’s opinions and work and learn together in an open and honest way to achieve their ambitious purpose. Job Overview: To driv...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Quality Engineer 		EU Not Disclosed

Senior Quality Engineer

Job title: Senior Quality Engineer Location: Glasnevin, Dublin 11 (on site role) Benefits: Top salary, Bonus, pension and Healthcare Company: My client are currently running clinical trials across Europe and the US, in collaboration with leading researchers and scientists who share our commitment to transforming the lives of the millions of people living with heart failure. They have a diverse team who respect each other’s opinions and work and learn together in an open and honest way to achieve their ambitious purpose. Job Overview: To driv...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Quality Engineer 		EU Not Disclosed

Principal Reliability Engineer

Job Title: Principal Reliability Engineer Location: Parkmore Galway Benefits: Bonus, Pension, Healthcare, Hybrid working (1 day from home) Job Purpose Cardiac Ablation Solutions (CAS) is an Operating Units within the Cardiac portfolio with my client. At CAS, the team are developing next generation medical technologies that treat patients with abnormal heart rhythms. Our technologies save lives and improve the quality of living for millions of patients across the world by advancing innovation for the diagnosis and ablation of cardiac arrhythmias...

Location: Galway, Galway City,
Principal Reliability Engineer 		Galway Not Disclosed

Senior R&D Engineer

Job title: Senior R&D Engineer (Sustaining) Location: Ballybrit, Galway Benefits: Competitive salary, bonus, pension and healthcare Company: My client are a leading global neurointerventional company based in Galway. Following an acquisition they holds a complete and globally competitive portfolio of neurointerventional products, with 5 R&D centres, 3 production bases, over 700 employees worldwide. Overall: The key individual was responsible for the product(s) that have been marketed previously. Provide leadership ...

Location: Galway, Galway City,
Senior R&D Engineer 		Galway Not Disclosed

Design Quality Engineer

Role: 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,
Design Quality Engineer 		Galway Not Disclosed

Design Assurance Engineer

Role: 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,
Design Assurance Engineer 		Galway Not Disclosed

Design Assurance Engineer

Job title: 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...

Location: Clare, Galway, Galway City, Limerick, Limerick City,
Design Assurance Engineer 		EU Not Disclosed

R&D Engineer

Job title: R&D Sustaining Engineer Location: Ballybrit, Galway Benefits: Competitive salary, bonus, pension and healthcare Company: My client are a leading global neurointerventional company based in Galway. Following an acquisition they holds a complete and globally competitive portfolio of neurointerventional products, with 5 R&D centres, 3 production bases, over 700 employees worldwide. Overall: The key individual was responsible for the product(s) that have been marketed previously. Provide leadership ...

Location: Galway, Galway City,
R&D Engineer 		Galway Not Disclosed

Design Assurance Engineer

Role: 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,
Design Assurance Engineer 		Galway Not Disclosed

Design Assurance Engineer

Job title: 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...

Location: Clare, Galway, Galway City, Limerick, Limerick City,
Design Assurance Engineer 		EU Not Disclosed

Project Manager Design Assurance

Job 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,
Project Manager Design Assurance 		Galway Not Disclosed

Senior Design Assurance Engineer

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 indi...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Design Assurance Engineer 		EU Not Disclosed

Project Manager Design Assurance

Job 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,
Project Manager Design Assurance 		Galway Not Disclosed

Design Assurance Program Manager

Job 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,
Design Assurance Program Manager 		Galway Not Disclosed

Design Assurance Program Manager

Job 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,
Design Assurance Program Manager 		Galway Not Disclosed

Quality Specialist

Job 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,
Quality Specialist 		EU Not Disclosed

Quality Specialist

Job 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,
Quality Specialist 		EU Not Disclosed

Quality Specialist

Job 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,
Quality Specialist 		EU Not Disclosed

Senior Project Engineer

Job title: Senior Project Engineer Location: Cootehill, Co. Cavan Company: My client are a global healthcare leader that helps people live more fully at all stages of life. With a portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Role: You will work within the Packing Department Projects division joining an established team of Engineers in the delivery of improvements to help integrate new products or processes i...

Location: Cavan, Fermanagh, Longford, Midlands, Roscommon,
Senior Project Engineer 		EU Not Disclosed

R&D Manager

Job title: R&D Manager Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and take great pride in providing a ...

Location: Connaught, Galway, Galway City,
R&D Manager 		Connaught Not Disclosed

R&D Manager

Job title: R&D Manager Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and take great pride in providing a ...

Location: Connaught, Galway, Galway City,
R&D Manager 		Connaught Not Disclosed

R&D Manager

Job title: R&D Manager Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and take great pride in providing a ...

Location: Connaught, Galway, Galway City,
R&D Manager 		Connaught Not Disclosed

R&D Manager

Job title: R&D Manager Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and take great pride in providing a ...

Location: Connaught, Galway, Galway City,
R&D Manager 		Connaught Not Disclosed

R&D Lifecycle Manager

Job title: R&D Lifecycle Manager Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and take great pride in pr...

Location: Connaught, Galway, Galway City,
R&D Lifecycle Manager 		Connaught Not Disclosed

Senior Project Engineer

Job title: Senior Project Engineer Location: Cootehill, Co. Cavan Company: My client are a global healthcare leader that helps people live more fully at all stages of life. With a portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Role: You will work within the Packing Department Projects division joining an established team of Engineers in the delivery of improvements to help integrate new products or processes i...

Location: Cavan, Fermanagh, Longford, Midlands, Roscommon,
Senior Project Engineer 		EU Not Disclosed

Quality Engineer

Role: 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,
Quality Engineer 		EU Not Disclosed

Senior R&D Manager

Job title: Senior R&D Manager Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and take great pride in provid...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior R&D Manager 		EU Not Disclosed

Senior R&D Manager

Job title: Senior R&D Manager, Lifecycle Management Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and ta...

Location: Athlone, Galway, Galway City,
Senior R&D Manager 		Athlone Not Disclosed

Senior R&D Manager - Lifecycle Management

Job title: Senior R&D Manager, Lifecycle Management Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and ta...

Location: Galway, Galway City,
Senior R&D Manager - Lifecycle Management 		Galway Not Disclosed

Senior R&D Manager - Lifecycle Management

Job title: Senior R&D Manager, Lifecycle Management Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and ta...

Location: Galway, Galway City,
Senior R&D Manager - Lifecycle Management 		Galway Not Disclosed

Senior Design Engineer

Company: My client are a Pharma and Medical Device company developing combination products who have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment Role: Senior Device Development Engineer Location: Newenham Court, Northern Cross, Malahide rd, D...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Design Engineer 		EU Not Disclosed

Senior Equipment Design Engineer

Company: My client are a Pharma and Medical Device company developing combination products who have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment Role: Senior Equipment Design Engineer Location: Newenham Court, Northern Cross, Malahide rd, Dub...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Equipment Design Engineer 		EU Not Disclosed

Senior R&D Manager - Lifecycle Management

Job title: Senior R&D Manager, Lifecycle Management Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and ta...

Location: Galway, Galway City,
Senior R&D Manager - Lifecycle Management 		Galway Not Disclosed

Senior Design Engineer

Company: My client are a Pharma and Medical Device company developing combination products who have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment Role: Senior Device Development Engineer Location: Newenham Court, Northern Cross, Malahide rd, D...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Design Engineer 		EU Not Disclosed

Senior R&D Manager - Lifecycle Management

Job title: Senior R&D Manager, Lifecycle Management Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and ta...

Location: Galway, Galway City,
Senior R&D Manager - Lifecycle Management 		Galway Not Disclosed

QA Engineer

Role: 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,
QA Engineer 		EU Not Disclosed

Product Development Engineer

Title: Product Development Engineer (Validation & Verification) Location: The Digital Hub, Rainsford St, Dublin 8. Benefits: Excellent salary, flexible working hours and Health insurance Role: As a Product Development Engineer you will gain exposure to a range of technologies at the forefront of biomedical research and every phase of the product development lifecycle from initial concept development through to commercialisation. Expand its engineering department to support development of flagship and next-generation medical device products that comb...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Product Development Engineer 		EU Not Disclosed

Senior Design Engineer

Company: My client are a Pharma and Medical Device company developing combination products whoare have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment Role: Senior Device Design Engineer Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 ...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Design Engineer 		EU Not Disclosed

Senior Equipment Design Engineer

Company: My client are a Pharma and Medical Device company developing combination products who have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment Role: Senior Equipment Design Engineer Location: Newenham Court, Northern Cross, Malahide rd, Dub...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Equipment Design Engineer 		EU Not Disclosed

Senior Equipment Design Engineer

Company: My client are a Pharma and Medical Device company developing combination products who have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment Role: Senior Equipment Design Engineer Location: Newenham Court, Northern Cross, Malahide rd, Dub...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Equipment Design Engineer 		EU Not Disclosed

Validation & Verification Engineer

Title: Product Development Engineer (Validation & Verification) Location: The Digital Hub, Rainsford St, Dublin 8. Benefits: Excellent salary, flexible working hours and Health insurance Role: As a Product Development Engineer you will gain exposure to a range of technologies at the forefront of biomedical research and every phase of the product development lifecycle from initial concept development through to commercialisation. Expand its engineering department to support development of flagship and next-generation medical device products that comb...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Validation & Verification Engineer 		EU Not Disclosed

Software Design Assurance Engineer

Software Design Assurance Engineer Our client in Dublin are looking to add a Software Design Assurance Engineer to their growing team. Our client are a global medical technology company founded to establish bimodal neuromodulation as a new standard of care for tinnitus, a condition that affects 15% of the global adult population. Main Purpose and Objective of the Position: You will work closely with colleagues to support the development, qualification, and commercialization of innovative, highly reliable, life changing medical devices and associated software. ...

Location: Dublin, Dublin City Centre, Dublin South,
Software Design Assurance Engineer 		Dublin Not Disclosed

Senior Design Assurance Engineer

Senior Design Assurance Engineer Our client a medical device company currently seeking a Design Assurance Engineer to join their team, The Design Assurance will be working in the Quality Assurance/Regulatory Affairs departmentteam responsible for Medical Product (CE Mark and FDA 510k) Design Assurance, Design Controls, Product and Process Validation System, and Risk Management Activities.​ Role/Responsibilities: Performs Design Assurance activities including technical reviews of design documentation and labelling, attends desi...

Location: Galway,
Senior Design Assurance Engineer 		Galway Not Disclosed

Senior Design Assurance Engineer

Senior 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,
Senior Design Assurance Engineer 		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