Job Title: Senior Design Assurance Engineer
We are seeking a highly skilled Senior Design Assurance Engineer to join our team in Galway. As a key member of our organization, you will play a vital role in ensuring the quality and safety of our medical devices.
The ideal candidate will have a strong background in design assurance and product development, with experience in leading risk assessments, design verification/validation, and DHF management. They will also be proficient in reviewing and approving technical documentation in line with ISO 13485 and FDA 21 CFR Part 820.
Additionally, the successful candidate will have excellent communication and problem-solving skills, as well as the ability to work effectively in a team environment. They will also possess a strong understanding of regulatory requirements and industry standards, including ISO 13485, FDA 21 CFR Part 820, and MDR.
Key Responsibilities:
* Lead risk assessments, design verification/validation, and DHF management.
* Review and approve technical documentation in line with ISO 13485 and FDA 21 CFR Part 820.
* Act as SME for audits and regulatory inspections.
* Partner with R&D and Manufacturing Engineering to translate design requirements into manufacturing processes.
* Support CAPA, audits, and continuous improvement activities.
* Mentor junior staff and provide QA guidance across teams.
Qualifications:
* Bachelor's degree in Engineering, Science, or related field.
* 5+ years' QA/RA experience in the medical device industry.
* Strong background in design assurance and product development.
* In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and MDR.
* Experience supporting notified body/FDA inspections.
* Strong communicator, problem solver, and team player.
Benefits:
This is an excellent opportunity to join a growing medical device company and contribute to the development of innovative products that improve patient outcomes.
How to Apply:
If you are a motivated and experienced professional looking for a new challenge, please submit your application to us today.