Senior Technical Lead Device Engineering
vor 4 Wochen
We are seeking a Senior Technical Lead to join our team at Novartis Pharmaceutical Manufacturing GmbH in Schaftenau, Austria. As a key member of our Global Device and Packaging Development department, you will be responsible for leading technical development and life-cycle management in cross-functional teams.
About the RoleAs Senior Technical Lead, your primary focus will be on easy-to-use, safe, and robust product development. You will lead device constituent parts of an autoinjector, system integration of prefilled syringes 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.
You will also ensure device design development is delivered to a high quality following the design control process and applicable regulatory framework. Your responsibilities will include writing key design history file documents: design input requirements, global component specifications, and design verification documents.
Key Responsibilities:- Lead technical development and life-cycle management in cross-functional teams for medical devices and combination products.
- 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.
- Write key design history file documents: design input requirements, global component specifications, and design verification documents.
- Ensure device design development is delivered to a high quality following the design control process and applicable regulatory framework.
- Ensure components are delivered and controlled to the required quality for clinical trials and commercial production.
In addition to these responsibilities, you will also support Regulatory Affairs to prepare medical device/combination product pre-registration documents and provide input to answer health authority questions.
RequirementsTo be successful in this role, you should have a Bachelor, Master, or PhD degree in engineering or equivalent. We prefer candidates with 8+ years of experience working in the development of medical devices and/or combination products; preferably in the pharmaceutical area or similar.
You should also have experience of preparing for submissions and launch as well as writing design history files. Excellent skills in English, verbal and written, are essential, and German language skills are an advantage.
What We OfferWe offer a market-competitive base salary of €89,600/year (on a full-time basis) and an attractive incentive program. In accordance with Austrian law, we are obliged to disclose the minimum salary. 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 also offer a modern company pension scheme, childcare facilities, learning and development opportunities, as well as worldwide career possibilities within the Novartis group. We are open to part-time and job-sharing models and support flexible and remote working where possible.
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