Job ID REQ-10068410
Location: Schaftenau, Austria #onsite

Role Purpose:
In a team dedicated to improving patient outcomes through innovative drug delivery solutions you will play a critical role in the development of drug delivery devices such as autoinjectors, prefilled syringes and other solutions. By ensuring that our products meet regulatory requirements and are designed with the end-user in mind you will contribute to our mission to design drug device combination products and medical devices that are not only safe and effective but also intuitive and user-friendly - whether for patients, caregivers, or healthcare professionals.About the RoleMajor accountabilities:

* Design, plan and perform Human Factors Engineering (HFE) activities collaborating with design teams across multiple or complex projects.
* Lead activities necessary for issuing HFE deliverables (user profile/capabilities, known use problems, task analysis, etc.).
* Support development of user requirements & their translation into design inputs based on user capabilities.
* Support risk management activities like planning, identification of use-related hazards & development of use-related risk analysis.
* Manage/Lead formative and summative evaluations with external vendors.
* Communication and negotiation of HFE challenges and risks to stakeholders and provide design recommendations.
* Develop labeling & instructional materials collaborating with design team.
* Establish HFE best practice within team and share lessons learned.
* Establish processes, templates, and guidance for application of HFE in device development.
* Disseminate knowledge & awareness of HFE within wider organization and contribute to publications, presentations, and patents.
* Support health authorities' communications & submission dossiers with regards to HFE activities.
* Support internal and external audits on medical devices and combination device related matters.
* Drive preparation of the function related documents (sections) for the registration of Medical Device/Combination Product and provide input to health authority related questions.
* Additional mutually agreed roles defined by trainings assigned.





Minimum Requirements:

* MSc in Human Factors Engineering, Cognitive Sciences, Behavioral Sciences, Biomedical Engineering, Psychology, Product Design, or Mechanical Engineering
* Several years job experience in HFE field, ideally in medical device / pharmaceutical industry

Skills:

* Human Factors Engineering including regulations
* Project Management.
* Technical Writing.

Languages :

* English.



In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is €65,605.54 EUR/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies



Adjustments for Applicants with Disabilities: If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Apply:

https://www.novartis.com/careers/career-search/job/details/req-10068410-senior-expert-human-factors-engineering