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Search Results for Design Assurance
Job Title. Location Salary Actions

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 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

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