Device Development Lead
vor 1 Tag
We are seeking an experienced Device Development Lead to join our Global Device and Packaging Development (GDPD) department in Schaftenau, Austria. As a key member of our team, you will be responsible for leading technical development and life-cycle management in cross-functional teams for easy-to-use, safe, and robust products as Medical Device Expert.
Key responsibilities include:
- Leading device constituent parts of an autoinjector, 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.
- Writing key design history file documents: design input requirements, global component specifications, and design verification documents.
- Ensuring device design development is delivered to a high quality following the design control process and applicable regulatory framework.
- Ensuring components are delivered and controlled to the required quality for clinical trials and commercial production.
You will work closely with Regulatory Affairs to prepare medical device/combination product pre-registration documents and provide input to answer health authority questions.
Requirements:
- Bachelor, Master, or PhD degree in engineering or equivalent.
- Preferably 8+ years of experience working in the development of medical devices and/or combination products; preferably in the pharmaceutical area or similar.
- Experience of preparing for submissions and launch as well as writing design history files.
- Experience in developing plastic and metal components; tolerance analysis, modeling, and testing.
The estimated salary for this position is approximately €89,600/year, depending on 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.
BenefitsWe offer a market-competitive base salary, 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.
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