Senior Expert Engineering
vor 2 Monaten
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 Medical Device 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 drug delivery systems including needle safety devices, inhalers auto-injectors, pen-injectors, on-body pumps, and ophthalmic drug delivery. 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 the drug formulation and provide the necessary compliant technical documentation for health authorities and production.
Your Responsibilities:
Your responsibilities include, but are not limited to:
- Lead technical development and life-cycle management in cross-functional teams for easy-to-use, safe and robust products as Medical Device Expert
- Work with third party suppliers and act as a technical expert for device development and industrialization partners
- 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
- Manage verification testing and characterization for acceptance, compliance, performance etc. and suggest improvements
- Perform root cause analysis and develop robust solutions to prevent re-occurrence
- 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
**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._
**Minimum 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
- Experience in designing plastic and metal components; tolerance analysis and math-modeling; lab testing
- Experience in material qualification
- Good knowledge in design for manufacturing and assembly
- Good knowledge in key regulations and standards (e.g. ISO23098, ISO 11608, ISO 10993, MDR, Design Controls)
- Design History File documentation
- Ability to interact with cross functional team in matrix organization
**Division**
Global Drug Development
**Business Unit**
TECHNICAL R & D GDD
**Country**
Austria
**Work Location**
Schaftenau
**Company/Legal Entity**
Sandoz GmbH
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
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