How you’ll spend your day
Work closely with R&D Device Teams within Teva to implement new devices and their technology to ensure successful knowledge transfer and on-time product launch.
Give feedback to the R&D device design teams based on operational requirements and capabilities.
Responsible for combination products risk assessment (e.g. pFMEA)
Responsible for coordinating successful qualification and validation activities required for the production of combination products.
Responsible for ensuring that all documentation generated by the site in support of combination products is written in accordance with relevant regulatory requirements.
Responsible for post launch device changes, managing post submission Design History File (DHF) updates in collaboration with R&D device teams.
Site expert and focal point for all device technical elements, consulting on investigations, CAPAs, scientific problem solving etc.
Your experience and qualifications
Bachelor of Science in Mechanical or Biomedical Engineering- Required
Master Degree- Preferred
Minimum of 3 years of experience in Medical Device industry or as Device engineer for combination products – Required
Experience with sterile / injection medical devices – Preferred
Strong presentation and communication skills- Required
Ability to work on multiple projects with aggressive timelines- Required
Ability to lead a small team of experts- Required
English – Speak fluent, write technical reports – Required
