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Details

Human Factors Engineer


Reference:AMJD-315087 Location: Dublin
England
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Human Factors Engineer
Our client are currently recruiting for a Human Factors Engineer for their medical device group. This group is the global headquarters for medical device design within the organisation. This is a permanent opportunity and can be based in Dublin or in the UK.

Responsibilities
• Define bespoke HF strategy and program for multiple Medical Device or Drug-Device Combination Product programs in line with global regulatory requirements, guidance’s and latest regulatory and industry thinking
• Develop human factors programs, conducting appropriate development and validation studies at key stages during the device development program
• Linking to clinical, regulatory and labelling teams as appropriate throughout the program
• Ensure that the HF program is integrated and current within the overall project plan
• Develop User-related design input requirements and lead User-focused Risk Assessment activities in collaboration with the Risk Management lead
• Develop and execute the design validation plan within device design controls and Quality Management Systems
• Ensure that the output of human factors studies are fed into the on-going device design and development program, development of Instructions for Use and Risk Management Plans
• Ensure that all activities are undertaken in compliance with the Quality Management System, inclusive of compliance with our ISO 13485 Certification

Requirement
• Science, Engineering or Psychology Degree
• Demonstrable experience of working under device design controls specifically in the area of Human Factors / Usability Engineering / User-focussed Risk Management
• Experienced in ISO/FDA requirements as applicable to device design and regulatory labelling
• Experience in the development of Combination Products/ Drug Device Systems within the pharmaceutical industry
• Experience of Design Iteration and Applied Design
• Knowledge of graphic design and associated software packages
• Proficiency in speaking, comprehending, reading and writing English is required

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252