Job Description
Design Assurance Engineer (Permanent) Oxford, UK:
We are seeking a motivated Design Assurance Engineer to join our global expansion. This role offers the opportunity to work in an innovative, fast-paced organisation committed to improving patient outcomes.
The Design Assurance Engineer will support quality assurance by ensuring regulatory compliant design life cycle documentation is produced and adhering to procedures and global standards.
This is a flexible, on-site role in Oxford to ensure effective control of the design and development, risk assessment, and change control, in collaboration with the R&D, Post-Market Engineering, and Quality teams.
Responsibilities:
* Assure design quality through the full lifecycle process in accordance with standards and procedures of a class III medical device.
* Complete relevant documentation and verification test reports for devices and systems, according to documentation procedures.
* Assist in design and risk review of new and existing medical devices.
* Support and conduct risk assessments and failure mode and effects analysis (FMEA) to identify and mitigate potential issues.
* Contribute as part of the team to assist in other tasks as necessary.
Requirements:
* Bachelor's degree within an engineering discipline or equivalent.
* 3+ years of experience within quality in the medical device industry.
* Experience with Class III or II medical device background.
* Expert knowledge of cGMP, 21 CFR 820, ISO13485, 14971, IEC 60601, 62304.
* Experience working in a full product development lifecycle environment, participating in design reviews, and ensuring design requirements are met.
Estimated salary: £60,000 - £80,000 per annum depending on experience.