I have partnered with an industry leading Medical Device company on their search for a Principal R&D (Cardiovascular) Engineer. They will be the lead expert within the R&D team, heading up the development of a cutting edge structural heart device, currently leading the way within the market!
Location: Ireland
Reporting directly to the Head of R&D, this role offers you the opportunity to play a leading role in the development of a Best-In-Class minimally invasive structural heart device; within an award winning and European and US VC backed Medical Device Company.
Responsibilities:
* Lead design and development at a system level.
* Design systems, including robust design selection, material selection and assembly method selection.
* 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.
* Ensure the device development follows good Design Control practices, in line with IOS13485.
* Ensure Quality in the product's design for durability, usability, reliability, functionality, marketability and manufacturability
* Lead technical discussions with multiple internal and external stakeholders
Must Haves:
* 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
If you would like to hear more about this role, contact me on:
02039295872
b.delaney@sciproglobal.com
