Job Title: Injection Device Technical Expert
Duration: 6 months initially (extension possible afterwards)
• Lead technical development activities for medical devices used in combination products eg. auto-injector or needle safety devices.
• Specify requirements of delivery system and device components.
• Work with third party suppliers to develop the device components and ensure a robust process is followed (specifications, mechanical design, DfM, DfA (Design for Manufacturing & Assembly ), tolerance analysis, risk analysis, testing)
• Work with third party suppliers to establish robust manufacturing process and map critical to quality design requirements to manufacturing controls
• Ensure components are delivered and controlled to the required quality for clinical trials and commercial production.
• Report in to the Device Project Leader and Delivery System Leader on all technical aspects related to the device development project.
• Co-ordinate technical activities with other functions responsible for primary and secondary packaging, human factors engineering, risk management and verification testing.
• Generate Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems. Author and Reviewer of DHF documents such as Design Input Requirements, Component Specifications, Design Verification Plan and Verification Summary Report. Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects.
• Ensure device design development in compliance with the regulations and delivered to a high quality.
• Root cause analysis of out-of-specification product and develop robust solutions to prevent re-occurrence.
An ideal candidate would have at least 8 years of experience in device development of parenteral delivery systems, e.g., drug/device combination products with main focus on medical devices for parenteral administration. The ideal candidate would have experience generating DHF documentation, including but not limited to design input requirements, technical specifications, design verification, design validation, and design transfer. They are organized and structured in their approach and able to drive a technical team to reach solutions that meet with drug development milestones.
Requirement for the role are:
• Excellent technical writing skills (e.g., Design Controls)
• Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)and of combination products (US)
• Experience in Product Design and Design for Manufacturing
• Good technical knowledge of primary containers development
• Good technical knowledge of needle safety devices or auto injector development
• Good organization and communication skills in English
• General understanding of Human Factors Engineering and Risk management
• General understanding of clinical trial processes and requirements
• General understanding of pharmaceutical development