I have partnered with an industry leading Medical Device company on their search for a Senior R&D (Cardiovascular) Engineer.
Location: Ireland
This role offers you the opportunity to play a pivotal role within the R&D Team, focusing on 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:
* Responsible for developing device specifications, in line with user needs and Design Inputs, including innovative solutions. Provide technical and project leadership for R&D activities
* Provide technical and project leadership for R&D activities
* Design sub assemblies and finished devices, including design selection, material selection and assembly method selection.
* Build and test prototypes
* Identify and select product materials, assembly methods and define process settings
* Develop test methods for product evaluation and validation. Develop and execute test method validations
* Drives risk management for sub-assemblies and drive a system level risk based design approach.
* Ensure quality in the product's design for durability, usability, reliability, functionality, marketability, and manufacturability
Must Haves:
* B.S. or master degree in mechanical engineering, biomedical engineering, or related disciplines
* Five years of related experience in medical device mechanical design/product development
* Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles. Prior experience in cardiovascular/nitinol/delivery system medical products highly preferred
* Strong capability of assessing in vitro and in vivo properties of device/device components including knowledge of the implant/tissue interface and challenges.
* Detailed knowledge of Design Controls and FDA, GMP, QSR and ISO 13485 requirements.
* Experience interfacing with clinicians and reducing feedback to device concept
* Excellent organizational and time management skills
If you would like to hear more about this role, contact me on:
02039295872
b.delaney@sciproglobal.com
