Our client a global healthcare currently seek a Principal Human Factors Engineer to join their team. The role is party of a global group that are working o development of a portfolio of medical devices.
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 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.
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.