Overview
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.
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.
Contract & Compensation
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.
Note: Sponsorship is not provided for this position.
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