
Medical Device Development Lead
15 hours ago
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
- 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
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