Lead Medical Device Risk Management & Control Strategy Engineer f/m/d

About the role

Location: Schaftenau, Austria, Hybrid working, #LI-Hybrid

As a Senior Expert Engineer for Risk Management & Control Strategy (RMCS) (Senior Expert Engineering) you will provide expertise in executing and maintaining control strategies and risk management business processes and tools for drug delivery devices and drug-device combination products. This will include designing, planning and performing RMCS activities within assigned Device Development projects and coordinating RMCS activities with the project team members for assigned projects. You will also author and review the deliverables assigned to RMCS and drive the preparation of the function related documents (sections) for the registration of Medical Device/Combination Product (examples: autoinjectors and needle-safety-systems, large-volume injectors, cell & gene therapy and radio-ligand delivery devices, oral dosing devices) and provide input to health authority related questions.

We are open to applicants based in or willing to relocate to Schaftenau or commutable to the site from Austria or Germany.

Key Responsibilities
• Establish risk assessments (e.g. Failure Modes and Effects Analysis) and all ISO 14971 related risk documentation for use, design and process related risks.
• Support the definition of design verification and process control activities.
• Communicate device risk related challenges and project risks to design team/cross functional team and provide design recommendations.
• Establish and apply RMCS best practice and share lessons learned.
• Establish SOPs, working practices, templates and guidance for the application of RMCS in device development.
• Disseminate knowledge and awareness of risk management within / outside Novartis.
• Support activities to collaborate with cross divisional stakeholders and to establish global policies relating to RMCS activities.
• Support internal & external audits and inspections on RMCS related matters for medical devices and combination device related matters.

Role Requirements

Essential Requirements
• BSc in Engineering or related technical field
• Experience gained in industry of Risk Management & Control Strategy. Ideally this will have been gained within Medical Devices but applications are welcomed from any industry
• Project Management experience
• Ability to read, interpret and apply information from global standards (ISO, AAMI, etc.)
• Excellent written and oral communication skills including technical writing in English

Desirable Requirements
• The ability to speak, read and write in German

Why Novartis
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:

You’ll receive
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Pay Transparency
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 € 60.212.18/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.

Commitment to Diversity and Inclusion
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 E-Mail auf sjobs.brassring.com ansehen 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.

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:

Commitment to Diversity & Inclusion:

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