Expert Engineering – Medical Device Development

Job Description Summary

Location:

Basel Switzerland #onsite

Role

Purpose:

At Novartis we are reimagining medicine to improve and extend peoples 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 devices our patients could not get their medicines. This is where you come in; the Device Technology Solution Center is looking for a Senior Design Engineer for the development of drug device combination products.

The aim is to develop a new Auto‑injector platform from early phase development to market launch.

Your responsibilities include but are not limited to:

• Work on Platform development and participate to project activities in cross‑functional teams for easy‑to‑use safe and robust products
• Participate to the complete development process of medical devices (ideation brainstorming prototyping piloting and transfer to manufacturing)
• Create and review IP
• Create manage and maintain CAD 3D and drawings
• Create manage and maintain Tolerance Analysis
• Size and specify plastic and metallic components
• Work with third party suppliers including prototyper tool makers CMOs
• Manage 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
• Write key design history file documents: design input requirements component specifications and design verification documents. Ensure device design development is delivered to a high quality

• Degree in mechanical engineering or equivalent
• Preferably 3 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; metrology; lab testing
• Experience in material qualification
• Good knowledge in design for manufacturing and assembly
• Good knowledge in key regulations and standards (e.g., ISO
  23098 ISO 11608 ISO 10993 MDR Design Controls)
• Design History File documentation
• Ability to interact with cross functional team in matrix organization
• Minimum 80% on site work 4 days/week

Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.

Employment Type:

Full‑Time |

Experience:

years | Vacancy: 1