Job ID: REQ-

LOCATION: Schaftenau, TYPE: Hybrid Working, Hybrid

Are you looking for a challenging and rewarding career in Combination Product Development with a brand new device? Do you want to be part of a team of talented and passionate engineers and scientists responsible for the development of parenteral combination products to ensure that our delivery systems fulfill the highest customer expectations? If yes, then this is the opportunity for you! The Device Technology Solution Center is seeking an Associate Director Engineering within the Global Device and Packaging Development (GDPD) department in Schaftenau, Austria.

Key Responsibilities:

1. Lead technical development and life-cycle management in cross-functional teams for easy-to-use, safe, and robust products as Medical Device Expert.
2. Responsible for device constituent parts of an autoinjector, the system integration of prefilled syringes together with the autoinjector into a combination product, and timely delivery of technical aspects of one or more projects as well as LCM of commercial products.
3. Write key design history file documents: design input requirements, global component specifications, and design verification documents.
4. Ensure device design development is delivered to a high quality following the design control process and applicable regulatory framework.
5. Ensure components are delivered and controlled to the required quality for clinical trials and commercial production.
6. Support Regulatory Affairs to prepare medical device/combination product pre-registration documents and provide input to answer health authority questions.
7. Support internal & external audits on medical devices related matters and provide input to health authority questions.
8. Bachelor, Master, or PhD degree in engineering or equivalent.
9. Preferably 8+ years of experience working in the development of medical devices and/or combination products; preferably in the pharmaceutical area or similar.
10. Experience of preparing for submissions and launch as well as writing design history files.
11. Experience in developing plastic and metal components; tolerance analysis, modeling, and testing.
12. Excellent skills in English, verbal and written. German language skills are an advantage.
13. Autonomous and independent working style with interest in medical device development and life cycle management projects.
14. Ability to interact with cross-functional teams in a matrix organization.

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!

You'll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. 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 €89,600/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 to part-time and job-sharing models and support flexible and remote working where possible.

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

If because of a medical condition, physical disability, or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to and let us know the nature of your request as well as your contact information. The support that 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.

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area: Research & Development

Job Type: Full time

Employment Type: Regular

Shift Work: No