This is a part time, fixed term position for up to 12 months in the first instance.
Salary: £36,694 – £49,210 per annum (Pro-Rated)
The Biomechanics group in the Department of Mechanical Engineering is developing a surgical power tool, set for first use in surgery in early 2023. We are a fast-growing team including engineers, regulatory, commercial and clinical advisors and closely linked to our spinout company Additive Instruments Ltd. By joining us you will be part of a close knit-team who is hugely motivated by improving surgery, and the life of patients, by translating cutting edge surgery from the lab to clinic. If you are interested in gaining hands-on experience of taking a surgical tool into the theatre, look no further!
Duties and Responsibilities
The primary goal of this post is to ensure that equipment is certified to allow it to be taken to market.
- You will be monitoring regulatory progress to ensure that regulatory requirements are met.
- You will maintain our 13485 system, including developing procedures and forms, and compiling quality records as required.
- You will assist in external and internal audits of our QMS, including auditing suppliers with our production lead.
- You will work closely with our partner company Additive Instruments Ltd. to ensure appropriate records of work are produced and maintained.
Skills, knowledge and experience
You must have a degree in engineering, or equivalent technical experience. A PhD in Medical Engineering is desirable.
- You should have experience of working within a regulatory/Quality framework Management System (QMS) in the medical device industry
- An understanding of the regulatory pathway of a device from prototype to clinical use is essential, as is an understanding of key medical device standards and quality requirements (for example ISO 13485, 60601, 62304 or CFR 21)
How To Apply
Our preferred method of application is via our website. Please visit our website using the provided link for more information about the post and the application process.