Device Development Technologist

Responsibilities

• 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.

Requirements 

• 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

Device Development Technologist Recruitment Agency in London, Injection Recruitment Agency in London