Medical Device Development Lead
We are seeking a highly skilled Medical Device Development Lead to join our team on a permanent basis. This role involves leading the design, development, and performance evaluation of medical devices to ensure they meet regulatory and quality standards.
The successful candidate will drive technical excellence, innovation, and patient-centric solutions through their expertise. They will lead cross-functional teams in developing and implementing test methods and specifications to assess device functionality and product performance.
This is an excellent opportunity for experienced professionals to contribute to the development of life-changing medical devices. If you have a passion for technology and innovation, we encourage you to apply.
Responsibilities:
* Lead the design, development, and testing of medical devices.
* Develop and implement test methods and specifications to assess device functionality and product performance.
* Collaborate with cross-functional teams to develop and implement new technologies.
* Ensure all activities within the team are conducted to appropriate quality standards within the Quality Management system.
* Provide technical support to manufacturing sites during filling and assembly process development.
* Apply statistical techniques and data analysis to inform design decision making and conclusions.
Requirements:
* Degree in Science or Engineering (Master's preferred).
* 7+ years' experience in medical device development.
* Working knowledge of design control requirements, preferably in line with FDA 21 CFR part 820 and ISO 13485.
* Experience in developing and validating analytical methods.
* Experience in applying statistical techniques for data analysis.
* Highly driven and motivated individual who can work as part of a flexible, dynamic team.
About Us:
We are a leading medical device company based in Dublin, Ireland. We are committed to delivering innovative medical devices that improve patient outcomes. We offer a dynamic and supportive work environment, competitive compensation packages, and opportunities for professional growth and development.