You will be a graduate in Mechanical Engineering, Biomedical Engineering or related degree. You will have experience of the development, manufacture, testing, and quality control of medical devices/combination products. Experience in the regulatory pathways for combination products is essential.
You must be able to demonstrate your ability to manage projects and small internal and external teams. Additionally you need to be able to demonstrate problem solving skills and utilisation of different strategies to support resolution of design, manufacturing and regulatory challenges. You must demonstrate your ability to effectively communicate the development programmes to the wider development team and stakeholders.
You will be required to work with the design team to;
• Manage the interface between the design team and the Project Team
• Manage the development and population of the Design History File in support of any new programme
• Responsible for the compilation of all regulatory files
• Responsible for management of governance reviews boards in support of the project team
• 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.
You should be able to demonstrate the following;
• 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
• Understanding of plastics injection moulding or other high volume
• Strong time management/organisational skills
• Performance driven, driving for results and success with a sense of urgency
• Evidence of team working skills and flexibility
All profiles will be reviewed against the required skills and experience. Due to the high number of applications we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply!
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