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.


Role/Responsibility

• 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.