Associate Director Engineering

About the Role

Key Responsibilities:

• 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.

Essential Requirements:

• 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.

Why Novartis?

You’ll receive:

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 for part-time and job-sharing models and support flexible and remote working where possible.

Commitment to Diversity & Inclusion:

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

Adjustments for Applicants with Disabilities:

Join our Novartis Network:

Zusammenfassung der Stellenbeschreibung

STANDORT: Schaftenau, TYP: Hybrid Working, #LI Hybrid

Sind Sie auf der Suche nach einer herausfordernden und lohnenden Karriere in der Entwicklung von Kombinationsprodukten mit einem brandneuen Gerät? Möchten Sie Teil eines Teams von talentierten und leidenschaftlichen Ingenieuren und Wissenschaftlern sein, die für die Entwicklung von parenteralen Kombinationsprodukten verantwortlich sind, um sicherzustellen, dass unsere Verabreichungssysteme die höchsten Kundenerwartungen erfüllen? Wenn ja, dann ist dies die richtige Gelegenheit für Sie Das Device Technology Solution Center sucht einen Associate Director Engineering in der Abteilung Global Device and Packaging Development (GDPD) in Schaftenau, Österreich.

Stellenbeschreibung

Verantwortungsbereiche:

• Leitung der technischen Entwicklung und des Life-Cycle-Managements in funktionsübergreifenden Teams für einfach zu bedienende, sichere und robuste Produkte als Medical Device Expert
• Verantwortlich für Gerätebestandteile eines Autoinjektors, die Systemintegration von vorgefüllten Spritzen zusammen mit dem Autoinjektor in ein Kombinationsprodukt und die rechtzeitige Lieferung der technischen Aspekte eines oder mehrerer Projekte sowie LCM von kommerziellen Produkten.
• Verfassen von Schlüsseldokumenten zur Konstruktionsgeschichte: Anforderungen an die Konstrukti