Project Engineer Carbon60 are working with a global organisation who are a market leader in the power management sector. They have sites across the UK...
Carbon60 are currently recruiting for an experience Project Engineer for a well know medical device company based in Hertfordshire working at a unique site focusing on R&D.
This position will be responsible for leading/managing project and small teams through the development, manufacturing, testing and quality control of new products. This will involve a heavy focus on ensuring products are regulatory standards and compiling design history files ready for regulatory submissions.
We are looking for someone who has previous experience working to these standards (ISO 13485) and can manage the governance reviews in support of a dedicated project team.
This position will work closely with the design team to manage the interface with the projects team, manage the development and population of design history files and compilation of regulatory files.
Further Responsibilities include:
- Accountable for the execution of patient handling studies, design verification, design validation and QbD protocols for each project * Establishment of manufacturing and quality control systems at external suppliers.
Proven track record in product and process development and validation * Experience with global submissions, agency interactions and authoring dossiers * Comprehensive understanding of design controls, including 21CFR 820.30, risk management processes (ISO 14971), QMS (ISO 13485), relevant human factors and usability guidance, EU MDR, etc * Excellent written and verbal communication skills * Excellent negotiation skills * Management of external manufacturing supply bases * An understanding of the principles of design for manufacture * Evidence of problem solving
This role will be on a 12-month contract basis.
Interviews are being held shortly for this position with immediate starts available.
If you want to work for one of the leading companies in the world apply now and one of our experienced consultants will be in touch.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. Carbon60 is a trading name of Carbon60 Limited an Employment Business/Agency.