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Search Results for Design Assurance
Job Title. Location Salary Actions

Validation and Verification Engineer

Title: Product Development Engineer (Validation & Verification) Location: The Digital Hub, Rainsford St, Dublin 8. Benefits: Excellent salary, flexible working hours, Hybrid working 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 me...

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

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 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
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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