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Head of R&D
Galway
R&D Manager
Galway
R&D Manager
Galway
Senior Recruitment Consultant
Republic of Ireland
R&D Director
Galway
Trainer
Dublin
Analytical Chemist
Tipperary
Chemical Engineer
Tipperary
Senior Recruitment Consultant
Republic of Ireland
Project Manager
Limerick
Recruitment Consultant
Republic of Ireland
Project Engineer
Republic of Ireland
Medical Device Director
Republic of Ireland
R&D Director
Galway
Project Engineer
Limerick
Process Engineer
Limerick
Project Engineer
Tipperary
Senior Manufacting Engineer
Republic of Ireland
R&D Engineer
Dublin
Quality Specialist
Tipperary
CQV Lead
Tipperary
R&D Manager
Galway
Senior R&D Engineer
Galway City
Responsible Person (RP)
Republic of Ireland
Project Engineer
Limerick
Senior Quality Engineer-Remote
Republic of Ireland
C&Q Lead
Tipperary
R&D Director
Galway
R&D Manager
Galway
Consultant
James Cassidy
Life Science

+353 1 5079250
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Search Results for Design Assurance
Job Title. Location Salary Actions

Manufacturing Engineer

Role : Manufacturing Engineer Location: Parkmore, Galway Benefits: Competitive salary, Bonus and Share options. Also work with new technologies to the market. Role: This is an exciting opportunity for someone passionate about developing their career in the Medical Device industry. My client are a Medical Device start up looking for a Manufacturing Engineer to work closely with R&D to develop their Next Gen Product. Get the chance to work on a full product lifecycle with components for inside the body giving real time feedback to Electronic softw...

Location: Galway, Galway City,
Manufacturing Engineer
Galway Not Disclosed

Senior Quality Engineer-Remote

Senior Quality Engineer-Remote Our client a startup medical device company currently seeks a Senior Quality Engineer to join their team. Reporting to Quality Engineering Manager the Senior Quality Engineer is responsible for Design Assurance and Quality Engineering support for the company’s novel medical device products. This role shall support the Quality Engineering Manager for Quality Assurance and Quality Control activities related to development, manufacturing, release, and testing of medical device products in compliance applicable device and drug regulat...

Location: Republic of Ireland,
Senior Quality Engineer-Remote
Republic of Ireland Not Disclosed

Senior Mechanical Engineer

Title: Senior Mechanical Engineer Location: The Digital Hub, Rainsford St, Dublin 8. Benefits: Excellent salary, flexible working hours and Health insurance Role: As a Senior Mechanical Engineer you will work in a dynamic work environment on a variety of commercial and research projects. Work with a range of technologies at the forefront of Biomedical research and every phase from concept to commercial release. Company: My client are a Medical Device company who started up in 2010 and have developed and patented a bimodal neuromo...

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

Senior Quality Engineer

Title: Senior Quality Engineer Location: Dublin 1 (Hybrid working) Company: My client are developing a Best-In-Class minimally invasive solution for severe Tricuspid Regurgitation (TR).It is a clear unmet clinical need, with a significant impact on mortality, cardiovascular events and quality of life. With a prevalence greater than aortic stenosis in the population over 65 years, TR is the next structural heart opportunity. Responsibilities: Support the development, implementation, and maintenance of the QMS in accordance with...

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

Design Assurance Supervisor

Role: Design Assurance Supervisor Location: Ballina(Hybrid working) Department: Continence Care Salary and benefits: Good salary, yearly bonus, pension and full family healthcare. Company : My client are one of the worlds leading Medical Device companies who manufacture a high volume of products for global distribution that support their ostomy care and continence care product lines using leading edge automated technologies. Summary: The Design Quality Assurance team is an integral part of developing and bringing to ...

Location: Mayo,
Design Assurance Supervisor
Mayo 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

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