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Details
Principal R&D Engineer
Reference: | JCAO20212 | Location: |
Dublin Greater Galway |
Qualification: | Degree | Experience: | 10+ Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Principal Engineer
Principal R&D Engineer
Our client a high potential start up is currently seeking a Principal R&D Engineer to join their team. Reporting to the head of R&D the Principal R&D Engineer will take the lead technical role in the product development of a cutting edge device through design development, verification, clinical trials, validation and regulatory approval. The technology being developed will address a key unmet clinical need and the Principal R&D Engineer will be a key member of the team and help drive the development of the technology.
Role/Responsibilities
- Lead design and development at a system level, generation of detailed specifications, including review and approval of sub-systems.
- 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.
- Manage the sourcing, building and testing of systems; ensuring detailed and comprehensive data analysis to drive the device design in the optimal direction
- Define and manage the execution of comprehensive test suites to fully understand device design, risk and verify & validate it in line with device specifications.
- Proactive management of risks throughout the product lifecycle to drive risk management at an overall system level, ensuring risk based design.
- Ensure the device development follows good Design Control practices, in line with ISO13485. Generating a complete, audit ready, Design History File.
- Ensure Quality in the product’s design for durability, usability, reliability, functionality, marketability and manufacturability
- 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.
- Proactively ensure Company Goals are achieved and act an example to others in embodying the Company Values
Education and Experience
- B.S. or Masters degree in mechanical engineering, biomedical engineering, or related disciplines
- 10 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 device/device components including knowledge of the implant/tissue interface and challenges.
- Detailed working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
- Experience interfacing with clinicians and reducing feedback to appropriate designs
- Experience with implantable cardiovascular devices and / or steerable catheter systems would be a distinct advantage
- Excellent organizational and time management skills
For further information please contact James Cassidy [email protected] or call 0860204322
Medical Affairs Cork Scientific Sales and Marketing PhD Biotechnology Limerick Biopharmaceutical Product Development Engineer Quality Engineering Pharmaceutical Quality Assurance Academic Scientist Supply Chain Life Science Laboratory Scientist Engineering Allied Healthcare Sales and Marketing Quality Control Packaging Engineer Manufacturing Executive Microbiology Diagnostics Clinical Research Chemistry Dublin Connected Health Academic Supply Chain Mayo Medical Device Pharma Sales Cork City IT Project Manager Validation Engineer
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2020 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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