Senior Expert Engineering - Risk Management (m/f/d)

apartmentNovartis Pharma GmbH placeLangkampfen calendar_month01.02.25

Summary

Senior Expert Engineering - Risk Management (m/f/d)

Location: Schaftenau, Tirol. Austria #Li-Hybrid

If you want to make the lives of patients easier and more comfortable, join our great team. We, the Risk Management and Control Strategy Department, accompany the medical device development process from the start of a new idea to market entry.

The entire development portfolio of Novartis is in our scope, providing great opportunities to learn and grow with the Novartis portfolio.

About the Role

Key Responsibilities:

Your responsibilities include, but are not limited to:

Organize input from other internal functions and apply the risk management process to compile documentation package related to risk management in the DHF and DMR.
Support the definition of design verification and process control activities. Communicate device risk related challenges and project risks to cross functional team and provide design recommendations.
Write scientific documents intended for external partners or for generation of registration documents, as well as interact with the health authorities.
Lead the transfer of know how to other departments or external contractors, including troubleshooting and on-site training (apply best practice and share lessons learned).
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.
Develop detailed plans and timelines with the manager, develop formulation strategies and plans for designated projects from development to cGMP manufacture.
Collaborate with cross divisional stakeholders to establish global policies and support audits.

Minimum Requirements:

Master of Engineering or a related field (Mechanical Engineering, Process Engineering, Electrical Engineering, Computer Science, Medical Engineering or similar) or equivalent experience.
Very good knowledge of English required, German knowledge beneficial.

Desirable requirements:

Previous experience in the field of medical device development or pharmaceutical industry advantageous.
Knowledge in the field of FMEA, risk management (ISO 14971 or similar).

You'll receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities 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 € 64.023,54/year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

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 working 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 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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

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

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