Medical Device Product Development Expert

1 day ago

Dublin, Dublin City, Ireland beBeeMedicalDevice Full time €90,000 - €125,000
Job Title: Medical Device Product Development Expert

We are seeking an experienced Medical Device Product Development Expert to join our team. As a key member of our product development team, you will play a lead role in the design, development, verification, clinical trials, validation, and regulatory approval of a cutting-edge medical device.

Key Responsibilities:
  • Lead the design and development of medical devices at a system level, generating detailed specifications, including review and approval of sub-systems.
  • Design systems, selecting robust designs, materials, and assembly methods, detailing finished device specifications for a robust and right-first-time device.
  • Manage the sourcing, building, and testing of systems, ensuring comprehensive data analysis to drive optimal device design.
  • Define and manage comprehensive test suites to fully understand device design, risks, and verify & validate it against device specifications.
  • Proactively manage risks throughout the product lifecycle to drive risk management at an overall system level, ensuring risk-based design.
  • Ensure device development follows good Design Control practices, generating a complete audit-ready Design History File.
  • Ensure quality in product design for durability, usability, reliability, functionality, marketability, and manufacturability.
  • Lead technical discussions with internal and external stakeholders, adapting and supporting material as needed.
  • Proactively ensure company goals are achieved.
  • Interact with colleagues and stakeholders while reflecting company values.
Requirements:
  • Bachelor's or master's degree in mechanical engineering, biomedical engineering, or related disciplines.
  • Eight years of related experience in medical device mechanical design/product development.
  • Cardiovascular medical product development experience preferred.
  • Comprehensive ability to assess in vitro and in vivo properties of devices/components, including implant/tissue interface knowledge and challenges.
  • Detailed working knowledge of FDA, GMP, QSR, and ISO 13485 requirements.
  • Experience interfacing with clinicians and reducing feedback to suitable designs.
  • Excellent organizational and time management skills.

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