Sumar
Role Purpose:
At Novartis, we are reimagining medicine to improve and extend people's lives. We discover and develop breakthrough treatments and find new ways to bring cures to as many people as possible.
Without safe, easy-to-use, high-quality drug delivery systems our patients could not get their medicines. This is where you come in; the Device Technology Solution Center needs you as Senior Expert Engineering for the development of drug device combination products working alongside our talented, bright and diverse teams.
Our Device Technology Solution Center drives the technical development of auto-injectors as well as novel drug delivery principles, e.g. drug delivery to the brain or radioligand therapy. We closely collaborate with project management, human factors engineers, packaging experts, analytical testing, production, external partners, regulatory experts and many more.
The aim is to develop and/or integrate innovative drug delivery systems with drug formulation and author state-of-the-art technical documentation for health authorities and production.
About the Role
Your Responsibilities:
Your responsibilities include, but are not limited to:
- Develop platforms and collaborate with cross-functional teams to deliver safe, user-friendly, and reliable products
- Lead and support teams in the field of assembly for parts/device, design equipment and process across from prototyping to commercial scale
- Create and maintain relevant Design History File (DHF) documents, ensuring high-quality device design and development
- Contribute to all phases of medical device development: ideation, prototyping, piloting, and manufacturing transfer
- Ensure components meet quality standards for clinical trials and commercial production
- Collaborate with external partners, including prototypers, toolmakers, and CMOs
- Identify root causes of issues, define and implement robust solutions
Role Requirements
- Degree in mechanical engineering or equivalent
- Preferably 5 years of experience in medical device development
- Proficient spoken communication and excellent technical writing skills in English
- Proven experience in assembly of plastic and metal components / sub-assemblies
- Proven experience in design for manufacturing and design for assembly
- Good knowledge in key regulations and standards (e.g. ISO 13485, ISO 23908, ISO 11608, ISO 10993, MDR, Design Controls)
- Ability to interact with cross functional team in matrix organization
- Minimum 80% on site work – 4 days/week
- Travels to visit suppliers and CMOs
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
