Would you like to work for a company that design and develop breakthrough consumer diagnostic products that are changing the lives of people all over the world?
Our clients are part of a joint venture between two global medical and pharmaceutical companies and are the leading supplier of home pregnancy and fertility/ovulation tests and are on a mission to empower women on their reproductive journey, by offering products which are reliable.
Purpose of role
To provide engineering expertise in the fabrication of sustainable paper, card, and non-woven materials, for the development of the next generation of consumer diagnostic products and packaging.
Furthermore, the position is required to contribute to the development of automated manufacturing processes though to final validation and market exploitation.
* Contribute to the design of consumer focused diagnostics and packaging, particularly utilising sustainable alternatives to existing materials.
* Contributes to the design of high throughput automated production processes.
* Work with project team to create and develop the necessary development documentation, protocols and reports, in compliance with an ISO 13485 certified quality management system.
* Involved in the assessment of potential automation partners for manufacture. Delivery of manufacturing trial batches of components and product assemblies.
* Uses appropriate methods of mechanical analysis (FEA, Tolerance analysis, etc), of designs to achieve robustness in operation and production.
* Maintain accurate and up to date records of all work carried out in accordance with the company QMS.
* A BEng (or equivalent) in materials, or mechanical engineering with relevant industrial experience, covering the full product development lifecycle from concept to manufacture.
* Experience of fabricating components and packaging using paper, card and non-woven materials.
* Experience and knowledge of automated manufacture, web based processing and assembly.
* Knowledge of production scale up, robustness and validation activities in accordance to relevant regulatory standards, preferably within the medical device arena.
* Excellent communication skills, including report writing and verbal presentations of findings.
* Experience of developing medical consumer diagnostics (preferably incorporating immunoassays) within a regulated environment (ISO 13485 and FDA 21CFR Part 820).
* An understanding process improvement tools and techniques (e.g. Six Sigma).
Experience of managing component and product manufacture in Far East