Senior Expert Engineering – Medical Device Development

Job Description Summary

Job Description

Your Responsibilities:

Your responsibilities include but are not limited to:

• Work on platform device development and participate to project activities in cross-functional teams to deliver easy-to-use safe and robust products
• Contribute to the complete development process of medical devices: ideation brainstorming prototyping piloting manufacturing and complaint handling
• Create and review IP
• Work with CAD 3D drawings 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 implement 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
• Author key design history file documents: design input requirements component specifications and design verification documents.

Role Requirements

• Degree in mechanical engineering or equivalent
• Preferably 10 years of experience in medical device development
• Proficient oral communication and excellent technical writing skills in English is a must
• 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 of key regulations and standards
• Track record in Design History File documentation
• Ability to interact with cross functional team in matrix organization
• Minimum 80% on site work 4 days/week

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.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to receive more detailed information about the essential functions of a position please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired