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Life Science Recruitment Leader | Pharmaceuticals | Medical Device R&D | Contract Recruitment | cormac@stemrp.ie
We are working with an established medical devices R&D company in Dublin that is seeking an experienced Senior Human Factors Engineer to join their organisation on an initial 12-month contract. This role offers very competitive hourly rates.
Role Overview:
Lead and execute human factors and design validation for medical device products, ensuring they meet user needs throughout the product lifecycle. Work as part of cross-functional teams on complex device projects.
Key Responsibilities:
* Understand customer needs, user groups, and environments to drive innovative product solutions.
* Design and manage formative and validation studies, including contextual inquiries and usability testing.
* Apply best-in-class validation techniques, set acceptance criteria, and ensure compliance with US/EU regulations and industry standards.
* Plan and execute studies in hospital or simulated environments; coordinate with external partners and vendors.
* Maintain validation documentation, ensure data accuracy, and communicate progress to stakeholders.
* Support the development of IFU and training materials, post-approval regulatory submissions, and technical responses to authorities.
* Write and revise technical documents (SOPs, protocols, reports).
* Maintain usability file documentation for assigned projects.
Qualifications:
* MS/PhD in biomedical engineering or medical device design, or MD/PhD in medicine.
* 5+ years’ experience in medical system design or human factors validation.
* 2+ years’ experience working with end users/patients in hospital or R&D settings.
* Proven experience in validation across the product lifecycle, using industry-standard techniques.
* Expertise in clinical evaluation, usability studies, or clinical trials.
* Excellent communication and leadership skills; detail-oriented and data-driven.
* Willingness to travel occasionally to EU/US for off-site testing.
Contract: 12 months, competitive hourly rates
Location: Hybrid (1-2 days onsite)
**Sponsorship is not offered for this role***
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Contract
Job function
* Job function
Design, Engineering, and Project Management
* Industries
Medical Equipment Manufacturing and Research Services
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