Novartis Pharma Schweiz AG seeks a Senior Expert in Engineering for Medical Device Development in Basel. The role focuses on creating a new auto-injector platform from early development through market launch.
This position sits within the Device Technology Solution Center, where the primary objective is to advance a novel auto-injector platform. The scope covers the entire lifecycle, starting from initial concept phases and extending through to commercial market release.
Responsibilities
- Collaborate within cross-functional groups to engineer platform devices that are safe, durable, and user-friendly.
- Guide medical devices through the full development cycle, including concept generation, prototyping, pilot runs, manufacturing setup, and addressing post-market complaints.
- Draft and evaluate intellectual property documentation.
- Utilize CAD and 3D modeling tools to produce drawings and conduct tolerance analysis.
- Determine sizing and specifications for both plastic and metal parts.
- Coordinate with external partners such as prototyping services, tooling manufacturers, and contract manufacturing organizations.
- Oversee testing and characterization efforts to verify acceptance, compliance, and performance, then apply findings to drive improvements.
- Conduct root cause investigations and engineer lasting solutions to stop issues from recurring.
- Guarantee that parts meet strict quality standards for both clinical trials and commercial manufacturing.
- Prepare essential Design History File records, including design inputs, component specs, and verification reports.
Requirements
- Bachelor's or higher degree in mechanical engineering or a comparable field.
- Ideally, a decade of hands-on experience in the medical device sector.
- Strong command of spoken English and exceptional technical writing abilities.
- Proven background in designing plastic and metal components, including tolerance analysis, metrology, and laboratory testing.
- Experience with material qualification processes.
- Solid understanding of design for manufacturing and assembly principles.
- Familiarity with relevant regulations and industry standards.
- Demonstrated history of maintaining Design History File documentation.
- Capacity to collaborate effectively within matrix-style, cross-functional teams.
- Willingness to work on-site at least four days per week (80% presence).
About the company
Novartis Pharma Schweiz AG is dedicated to transforming medicine to enhance and prolong human life. The organization focuses on discovering innovative treatments and finding new ways to bring cures to as many people as possible.
- The company is reimagining medicine to improve and extend people's lives.
- Novartis discovers and develops breakthrough treatments and finds new ways to bring cures to as many people as possible.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.