Your responsibilities include, but are not limited to:
* Project leadership (planning, coordination, specifications, risk management, documentation, design transfer)
* Development oversight including detail design; ergonomics and usability (including HF/UE documentation); lead design reviews
* Creation and management of Design History Files and associated documentation for selected combination products per the annual plan and objectives, and relevant standards and guidelines e.g. ISO13485, 21 CFR Part 820.30, 21 CFR 3.2(e).
* Lead, represent, and manage cross-functional device project teams.
* Management of activities following project strategies, budget, timelines, regulatory, quality, and professional standards.
* Enabling operational excellence in compliance with the current and anticipated professional trends
* Performing activities in compliance with Good Manufacturing Practices
* Ensuring inspection readiness.
What you’ll bring to the role:
* University degree in a relevant subject (mechanical engineering, product design, physics etc.) or other equivalent degree with 5+ years of experience
* Work experience with combination products (or device constituent parts thereof) or standalone medical devices development.
* Knowledge of GMP and international device regulations;
* Knowledge of regulatory/QA requirements for medical devices/combination products
* Ability to communicate and collaborate effectively in a highly international and diverse setting;
* Digital excellence and automation of documentation management.
* Track record of goal-driven behaviour, problem-solving, ability to make pragmatic decisions, and readiness for new challenges
* Fluency in English
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 EUR 64.023,54/year (on a full-time basis).
In most cases, however, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provides more than 800 million patient treatments to over 700 million patients every year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit are powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
Are you ready to join us? Then we look forward to your application!
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and fostering diverse teams, that represent the patients and communities we serve.
If you require assistance during the application process due to a medical condition, physical disability, or a neurodiverse condition, please contact us at jobs.austria@sandoz.com.
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