Device Development Lead

vor 1 Tag


Innsbruck, Tirol, Österreich Novartis Farmacéutica Vollzeit
About the Role

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.

Benefits

We 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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