Job Description
The role of Principal Device Development Assurance Scientist/Engineer involves supporting and guiding device development programs throughout the design and development lifecycle for combination products, including prefilled pens, prefilled syringes, autoinjectors, and medical devices.
This includes establishing, maintaining, and providing guidance on the contents of Design History Files for development programs.
Collaboration with affiliate sites, collaborators, and third parties is essential to ensure appropriate objective evidence and controls are established and maintained in line with program deliverables.
This position requires a strong understanding of quality management systems, regulations, and international standards relevant to medical devices.
The successful candidate will have experience in similar roles within the medical device or pharmaceutical industry and possess a degree in engineering or a life science.
Key Responsibilities
* Support and provide guidance for device development programs through the design and development lifecycle.
* Establish and maintain Design History Files for development programs.
* Collaborate with affiliate sites, collaborators, and third parties to ensure compliance with regulations and standards.
Requirements
* Master's degree in engineering or life science.
* Proven experience in similar roles within the medical device or pharmaceutical industry.
* Degree qualification in GMP environment.
Benefits
This is an exciting opportunity to work on cutting-edge projects and contribute to the success of the organisation.
We offer competitive salaries and benefits in an inclusive environment where you can use your experiences, perspectives, and skills to make an impact on the lives of others.