Principal Human Factor Engineer

Recruiter
Life Science Recruitment
Employment Type
Permanent
Salary
Not disclosed
Life Science Recruitment logo

Our client a Global Healthcare company currently seeks a Principal Factors Engineer to join their team based in a Irish Based Global R&D Group

Role/Responsibilities:

  • Lead the User Interface development (Human Factors and Usability Engineering) of a new  Platform in line with relevant guidelines and standards.
  • Develop Human Factors Strategy as key part of Inhaler development program to conclude with successful Design Validation
  • Develop User Requirements of device, labelling and packaging elements of the combination product based on detailed understanding of innovator device product and the intended user profile.
  • Drive these User Requirements through the development program, integrating Risk Management considerations throughout the process.
  • Working closely with Design Engineers ensure that Industrial Design is reflective of the User Requirements and iteratively tested throughout the inhaler development program.

Skills/Experience:

  • Scientist or Engineer with considerable experience in the Medical Device or Pharmaceutical Industry, preferably in the development of Respiratory Combination Products.
  • Strong experience in Human-centered design methodologies
  • Experienced in leading the execution of simulated testing from early patient handling studies through to Design Validation / Summative Human Factors studies.
  • Extensive experience of the integration of Risk Management considerations and User Requirements into iterative, patient-centered Device Design.
  • Proficient in Adobe Illustrator graphics tool.
  • Confidence in execution of a development program within the requirements of Design Control, Risk Management  (ISO14971), QMS (ISO13485), Human Factors and Usability standards and guidance (incl ISO62366, HE75), EU MDR etc.
  • Excellent verbal and written communication skills including technical reports and regulatory dossier preparation.

 

For further information please contact James Cassidy or call in confidence