Associate Director Engineering - Device Technology (m/f/d)

Novartis

Schaftenau
Feste Anstellung
Teilzeit, Vollzeit
Homeoffice möglich
Remote / vor Ort
Senior (5+ Jahre)
Österreich
Gehalt anzeigen
Erschienen vor 1 Jahr

Deine Aufgaben

Lead technical development and life-cycle management in cross-functional teams for easy-to-use, safe and robust products as Medical Device Expert
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.
Support Regulatory Affairs to prepare medical device/combination product pre-registration documents and provides input to answer health authority questions.
Support internal & external audits on medical devices related matters and provide input to health authority questions.

Dein Profil

Bachelor, Master or PhD degree in engineering or equivalent
Preferably 8+ years of experience working in development of medical device and/or combination products; preferred in 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
Excellent skills in English, verbal and written. German language skills are of advantage
Autonomous and independent working style with interest to work in medical device development and life cycle management projects.
Ability to interact with cross functional team in matrix organization.

Deine Benefits:

Attractive incentive program
Modern company pension scheme
Childcare facilities
Learning and development opportunities
Worldwide career possibilities within the Novartis group
Support for part-time and job-sharing models
Flexible and remote working options where possible

Weitere Informationen

Bevorzugte Sprachen:

Deutsch

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Ansprechperson

Novartis

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