Provide inputs for human centred design engineering for a range of projects across all phases of development

You will effectively communicate your work to the wider development team and stakeholders.

You will be involved in problem solving and utilisation of different strategies to support resolution of design, risk and regulatory challenges.

Support the execution of early patient handling studies (formative studies), identification and maintenance of user needs, conducting user related risk assessments, planning and execution of design validation activities

Ensure user needs are considered early and continuously throughout the design process

Support the interface between the external vendors and the Human factors Team

Management of external HF vendors

Support the development and population of the Design History File as it pertains to design Validation

Author sections of regulatory files

Graduate in Mechanical Engineering, Biomedical Engineering or related degree ( Physchology).

Practical experience and knowledge of human factors and usability regulatory framework, including FDA guidance, IEC 62366 and ANSI/AAMI HE75 and expectations for medical devices/combination products.

Experience on the development, manufacture and integration of end user inputs (user needs and risk related scenarios) of medical devices/combination products.

Working experience in product development and design validation as well as in the regulatory pathways for combination products is a must global submissions, agency interactions and authoring dossiers

Experience with integration of risk factors and user inputs into device design

Ability to analyse and summarise data and translate them into devices/combination products design recommendations

Excellent written and verbal communication skills as well as great attention to detail

Strong time management/organisational skills

Evidence of team working skills and flexibility

Experience with combination product and/or parenteral device development would be beneficial