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Quality Engineer
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Galway
Senior R&D Engineer
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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
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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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