Human Factors Engineering Expert (m/f/d).

Job Description

300 million! This is the number of people worldwide who are suffering from autoimmune disease and who would benefit from less expensive medication. As a Human Factors Engineering Expert (m/f/d), you will be responsible to design drug delivery systems to meet the needs of our patients in collaboration with other teams and partners, to enable new combination product launches.

Your key responsibilities:
• 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 labelling & 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

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

Essential:
• University degree in Biochemical/Biotechnology Engineering (Dipl. Ing, B.Sc, M.Sc) or equivalent.
• Relevant technical and cross-cultural senior engineering & leadership experience in the pharmaceutical industry.
• Fluent in English, German a plus.
• Knowledge of medical device regulations and medical device design control process.
• Knowledge and understanding of scientific principles and concepts in medical device / pharmaceutical / biological sciences as well as a good understanding of cGMPs, industry and regulatory standards and guidelines.
• Good interpersonal skills coupled with demonstrated networking capacities to ensure effective working in a matrix organization and a multi-disciplinary team environment.
• Skills with communicating and collaborating online.

Desirable requirements:
• Working with internal and external project groups and leading them.

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. 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 € 54,788.30/year (on a full time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications. We are open for part-time and job sharing models and support flexible and remote working where possible.

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network