We are working with a medical devices R&D company, based in Limerick, that is seeking a
Design Engineer or Design Assurance Engineer
with 3–5 years' experience in medical device development. This role will focus on supporting new product design activities, ensuring high‑quality documentation, and enabling compliance with regulatory standards.
Key Responsibilities:
* Support medical device design and development activities in line with regulatory and quality requirements.
* Generate, review, and approve Design History File (DHF) documentation.
* Utilise Cognition Cockpit for design control, requirements management, and traceability.
* Participate in design reviews and cross‑functional collaboration with R&D, Quality, and Manufacturing teams.
* Ensure compliance with ISO 13485, FDA, and EU MDR requirements for design control.
Requirements:
* 2–5+ years' experience in medical device design and/or design assurance.
* Proficiency with Cognition Cockpit or similar design control tools.
* Strong knowledge of medical device development processes and quality systems.
* Experience in
DHF (design history file) documentation generation and approval
.
* Degree in Biomedical or Mechanical Engineering.
This is an initial
12-month contract role,
with view for an extension or potential to become permanent.
€45-58/hour
DOE
3 days onsite
per week is required.
If you are interested, please apply using the links provided. Please note that sponsorship is not provided for this position.