Design Assurance Engineer Role
Job Description
This is a highly specialized role requiring an expert in design assurance engineering to work within the quality system to ensure compliance with regulations and standards.
The successful candidate will have a deep understanding of ISO 13485, ISO 14971, and FDA QSRs, as well as experience with statistics, validation, and physical testing.
Responsibilities include supporting the development and evolution of design control systems, providing input to R&D project teams, leading risk management activities, and developing verification and validation plans.
This role requires strong communication and collaboration skills, with the ability to lead human factors/usability engineering activities and support the preparation and delivery of design transfer reviews.
Required Skills and Qualifications
* A degree-level qualification in Engineering, Science, or a related field
* Upwards of 3 years' relevant experience in the medical device industry, preferably with stent or Class III device design assurance experience
* Knowledge of Medical Device Directives and Regulations (MDD, MDR, FDA)
* Familiarity with statistics, validation, and physical testing
Benefits
* Competitive salary
* Bonus scheme
* Pension contribution
* Full family healthcare
* Hybrid working arrangement
Others
This is a fantastic opportunity for an experienced design assurance engineer to join a rapidly growing medical device company and contribute to the development of innovative solutions.