Senior Technical Manager Devices (m/f), MS&T Aseptics, Schaftenau, Austria
150! This is the number of countries, where our innovative biotechnological medical device products reach patients. As part of the Manufacturing Science & Technology team, you will work at the front line to make a difference to millions of patients around the world by supporting the life cycle management and continuously improving our medical device or combination products.
Your responsibilities include, but are not limited to:
• Owns the knowledge of specific medical device manufacturing process technologies across the Aseptics platform sites
• Manage the Design History file/Design Dossier/ Device Master Record for assigned devices and combination products
• Manages all lifecycle activities for specific devices and leading related harmonization and improvement projects
• Subject Matter Expert SME for Technology platform and medical device processes
• Single Point Of Contact (SPoC) for the technology and interface with manufacturing sites, global MS&T network or technical development organization
• Maintain their work in inspection readiness level and provide the necessary support in any internal or external audit
What you'll bring to the role:
• BSc. (or higher) in Mechanical Engineering, Medical Device Technology or equivalent engineering / scientific degree
• Excellent English required (oral & written), German beneficial
• Minimum 5 years' experience in GMP manufacturing for medical devices or combination products as well as design control, documentation, risk management and processes such as DMR (Device Master Record), DHF (Design History File), pFMEA, Design Verification
• Curious, open minded, problem solving attitude
• Proven track record in working in interdisciplinary teams. Demonstrated active contributions to matrix teams
• Excellent communication skills and project management skills
• Proven process understanding (Medical Device directives, GMP, Regulatory aspects, QbD)
• Knowledge or expertise in injection molding, medical devices assembly and/or Software as medical devices
• Certified Green six sigma Black belt
Why consider Novartis?
750 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least EUR 50,374.38 per year on a full time basis).
We are Novartis. Join us and help us reimagine medicine.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Your responsibilities: Your responsibilities include, but are not limited to: • Responsible for leading cross functional teams for drug/device combination products and projects, ensuring the medical device requirements...
Your responsibilities: Your responsibilities include, but not limited to: • Define the business team with the relevant SME's to support the project lifecycle (planning, requirements, configuration, testing, training, etc...
Your responsibilities: Your responsibilities include, but not limited to: • Ensure technical GMP compliance with national regulations, Novartis guidelines, procedures and standards • Support of audits and inspections...