Electromechanical Medical Devices Development Manager

1 week ago

Galway, Galway, Ireland beBeeEngineering Full time €80,000 - €100,000

Medical Device Innovation Leader

The ideal candidate will drive the design and development of electromechanical medical devices, providing technical leadership and maintaining the Design History File throughout the product lifecycle.

Key Responsibilities:

  • Contribute to the product development process from concept generation to commercialization.
  • Participate in clinical trials or user evaluations to provide actionable feedback on device design.
  • Engage with end users to optimize product design and functionality.
  • Maintain product documentation and ensure compliance with quality standards.
  • Apply new and existing technologies to achieve optimal device design solutions.
  • Guide project planning and deliver devices within technical requirements.
  • Mentor and support team members' professional development.
  • Assist in intellectual property generation and protection arising from development activities.

Requirements:

  • Bachelor's or Master's degree in Engineering, Science, or equivalent field.
  • 5-8 years of experience in medical device product development, with proven leadership experience.
  • Knowledge of ISO 13485 and FDA 21 CFR Part 820 Design Control requirements.
  • Experience with catheter technology, design, testing, and manufacturing is a strong advantage.
  • Familiarity with engineering tools such as DOE, SPC, and statistical software.
  • Working knowledge of biocompatible metals and/or polymers.
  • Occasional travel to support project objectives.

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