Our client a hight potential medical device start up are currently seeking a Principal R&D Engineer to join their team. Reporting to the VP of R&D the Principal R&D Engineer will play a lead role in the product development of a cutting edge device through design development, verification, clinical trials, validation and regulatory approval.
Role/Responsibilities:
1. Lead design and development at a system level, generation of detailed specifications, including review and approval of sub-systems.
2. Design systems, including robust design selection, material selection and assembly method selection. Detailing finished device specifications to ensure a robust and right first time device.
3. Manage the sourcing, building and testing of systems; ensuring detailed and comprehensive data analysis to drive the device design in the optimal direction
4. Define and manage the execution of comprehensive test suites to fully understand device design, risk and verify & validate it in line with device specifications.
5. Proactive management of risks throughout the product lifecycle to drive risk management at an overall system level, ensuring risk based design.
6. Ensure the device development follows good Design Control practices, in line with IOS13485. Generating a complete, audit ready, Design History File.
7. Ensure Quality in the product's design for durability, usability, reliability, functionality, marketability and manufacturability
8. Lead technical discussions with multiple internal and external stakeholders, adapting s and supporting material to suit the discussion to ensure clear understanding of all parties.
9. Proactively ensure Company Goals are achieved
10. Ensure interactions with colleagues/stakeholders fully reflects the company values:
Skills/Experience
11. B.S. or masters degree in mechanical engineering, biomedical engineering, or related disciplines
12. Eight years of related experience in medical device mechanical design/product development
13. Cardiovascular medical product development experience preferred
14. Comprehensive ability to assess in vitro and in vivo properties of device/device components including knowledge of the implant/tissue interface and challenges.
15. Detailed working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
16. Experience interfacing with clinicians and reducing feedback to appropriate designs
17. Excellent organizational and time management skills
For further information please contact James Cassidy or call in confidence 086 0204322