Lead Medical Device Development Specialist
Our Dublin-based client is currently recruiting for a highly skilled medical device development professional to join their Device and Product Performance team on a permanent basis.
You will lead the design, development, and performance evaluation of drug-device combination products, ensuring they meet regulatory and quality standards.
Your expertise will drive technical excellence, innovation, and patient-centric solutions. As a key member of our team, you will be responsible for leading the development of medical devices from concept to launch, while ensuring compliance with relevant regulations and standards.
Key Responsibilities:
* Provide subject matter expertise to support the development of combination products
* Plan and execute design verification and reliability strategies
* Be the technical interface between drug product and device teams during combination product development
* Develop test methods and specifications to assess device functionality and product performance
* Responsible for material assessment of device components
* Provide technical support to manufacturing sites during filling and assembly process development
* Use statistical techniques or data analysis to inform design decision making
* Ensure all activities within the team are conducted to the appropriate quality standards
Requirements:
* Degree in science/engineering (master's preferred)
* 7+ years' experience in pharmaceutical and/or medical device development
* Working knowledge of design control requirements would be an advantage
* Experience in the development and validation of analytical methods
* Experienced in applying statistical techniques for data analysis
* Experience of writing and supporting regulatory submissions
* Highly driven and motivated individual who can work as part of a flexible, dynamic team