Summary
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 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 Role
Major accountabilities:
- Oversee and lead all activities of assigned teams /projects; meet customer needs.
- Work according to appropriate standards for quality, ethics, health, safety, environment, protection and information security; lead initiatives to ensure continuous improvement; all activities have to be aligned with organizational workflows and procedures.
- Evaluate and interpret results, draw relevant conclusions; supervise project related activities; perform complex tasks without having established procedures.
- Oversees and may also write protocols, scientific reports, lab procedures or process.
- related SOPs; write scientific documents intended for external partners or for generation of registration documents; interact with authorities -Communicate, address and solve problems within own and broader area of responsibility; communicate effectively across organizational interfaces; lead the transfer of know how to other departments or external contractors, including troubleshooting and on-site training.
- For technical development units: Develop complex methods (lab or plant); lead the optimization of project related scientific /technical activities or processes, co-ordinate local team(s); guide development and implementation of new technologies.
- For GMP units: ensure compliance to cGMP.
- For technology focused role: Provide scientific and technical guidance; actively foster knowledge exchange.
- Develop, mentor and coach other scientific associates; present scientific /technical results internally and contribute to publications, presentations and patents.
- For project-focused role: Lead assigned teams; represent own technical function in teams and fulfill all project tasks and responsibilities related to the own discipline -Broadly uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways -Contributes to many cost center goals and objectives; may contribute to service line goals .
Specific tasks for Human Factors Engineering:
- Design, plan and perform Human Factors (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
Skills:
- Human Factors Engineering
- Project Management.
- Sop (Standard Operating Procedure).
- 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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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 [email protected] 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.
