Job Title: Design Assurance Engineer
Job Type: Permanent
Location: Oxford, UK
A world-leading medical technology company developing innovative solutions is seeking a motivated Design Assurance Engineer to join the team as part of its global expansion. This is an opportunity to work in an innovative, fast-paced global medical device organization committed to improving patient outcomes. The role of Design Assurance Engineer is responsible for supporting quality assurance by ensuring regulatory compliant design life cycle documentation is produced, confirming adherence to procedures and global standards, and participating in design verification testing. The Design Assurance Engineer will join a rapidly growing Quality department and be involved in the quality assurance of the full development lifecycle of new and existing products.
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:
1. Assure design quality through the full lifecycle process in accordance with standards and procedures of a class III medical device.
2. Complete relevant documentation and verification test reports for devices and systems, according to documentation procedures.
3. Assist in design and risk review of new and existing medical devices.
4. Support and conduct risk assessments and failure mode and effects analysis (FMEA) to identify and mitigate potential issues.
5. Contribute as part of the team to assist in other tasks as necessary.
Requirements:
1. Bachelor’s degree within an engineering discipline or equivalent.
2. 3+ years of experience within quality in the medical device industry.
3. Experience with Class III or II medical device background.
4. Expert knowledge of cGMP, 21 CFR 820, ISO13485, 14971, IEC 60601, 62304.
5. Experience working in a full product development lifecycle environment, participating in design reviews, and ensuring design requirements are met.
Please reach out to Emily.james@skillsalliance.com or call 02033765104 for further details.
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