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Details
Principal R&D Engineer
Reference: | JCAO0115 | Location: |
Dublin |
Qualification: | Degree | Experience: | 7-9 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Principal Engineer, R and D Manager
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:
- 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 IOS13485. 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
- Ensure interactions with colleagues/stakeholders fully reflects the company values:
- B.S. or masters 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 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
- Excellent organizational and time management skills
Project Manager Cork Scientific Engineering Pharma Sales Diagnostics Clinical Research Sales and Marketing Medical Device Pharmaceutical Biotechnology Chemistry PhD Quality Assurance Limerick Quality Control Microbiology Quality Engineering Connected Health Allied Healthcare Manufacturing Executive Packaging Engineer Mayo Supply Chain Academic Sales and Marketing Life Science Medical Affairs Product Development Engineer Cork City IT Dublin Laboratory Scientist Validation Engineer Biopharmaceutical Academic Scientist Supply Chain
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 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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