Job Overview
We are seeking a Senior Design Assurance Engineer to join our team. This role will be responsible for the development of new technologies and ensuring compliance with relevant regulations.
* Developing and implementing design control, risk management, and related systems for new product development technologies.
* Providing design assurance input to R&D project teams and understanding regulatory requirements.
* Leading specification development and participating in generating Design Input/Output documents.
* Leading risk management activities for projects and design changes.
Requirements
To be successful in this role, you will need:
* A degree in Engineering, Science, or a related field.
* Over 5 years of relevant experience in the medical device or pharmaceutical industry.
* Understanding of ISO 13485, ISO 14971, and FDA QSRs.
* Familiarity with statistics, validation, and physical testing.
* Good communication and organizational skills.
Benefits
This role offers a challenging and rewarding career opportunity with a competitive salary and benefits package.
How to Apply
If you have the skills and experience required for this role, please submit your application.