Medical Device Development Role
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* Lead the development of cutting-edge medical devices through design, verification, clinical trials, validation and regulatory approval.
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Key Responsibilities:
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1. Develop detailed specifications for sub-systems, including review and approval.
2. Design systems, selecting materials and assembly methods to ensure a robust device.
3. Manage sourcing, building, and testing systems, analyzing data to drive design decisions.
4. Define and execute comprehensive test suites to verify and validate device design.
5. Proactively manage risks throughout the product lifecycle, driving risk-based design.
6. Maintain good Design Control practices, generating an audit-ready Design History File.
7. Ensure quality in product design for durability, usability, reliability, functionality, marketability, and manufacturability.
8. Lead technical discussions with stakeholders, adapting information to suit discussion needs.
9. Ensure interactions reflect company values.
10. Assess in vitro and in vivo properties of devices, including knowledge of implant/tissue interfaces and challenges.
11. Detailed working knowledge of FDA, GMP, QSR, and ISO 13485 requirements.
12. Interfacing with clinicians, reducing feedback to appropriate designs.
13. Excellent organizational and time management skills.
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For further information, please contact James Cassidy or call in confidence 086 0204322.
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