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Senior R&D Engineer

Reference:	JCAO2211	Location:	Dublin
Qualification:	Degree	Experience:	5-7 Years
Job Type:	Permanent	Salary:	Not Disclosed

May be suitable for: Senior Research and Development Engineer

Our client a high potential and well funded start up are currently seeking a Senior R&D Engineer to join their team. Reporting to Director of R&D Senior R&D Engineer will support the product development of a cutting edge device through design development, verification, clinical trials, validation and regulatory approval. This position offers the opportunity to join an exciting early stage company.

Role/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
Design sub assemblies and finished devices, including design selection, material selection and assembly method selection. Create detailed component and finished device assembly drawings/specifications
Build and test prototypes; analyse test data and interpret to identify optimal solution
Identify and select product materials, assembly methods and define process settings. Participate in sourcing, testing and approving materials.
Develop test methods for product evaluation and validation. Develop and execute test method validations.
Leverage and liaise with external resources to achieve project goals
Drives risk management for sub-assemblies under their responsibility and drives a system level risk based design approach.
Ensure quality in the product’s design for durability, usability, reliability, functionality, marketability, and manufacturability
Ensure interactions with colleagues/stakeholders fully reflects the company values:

One Team: working together to ensure the whole is greater than the sum of the parts
Personal Ownership: deliver on commitments
Open Communication: Honest open-minded communication
Fun: celebrate the successes
Continuous Learning: at an individual and company level
Solution Orientated: Identify problems but focus your energy on solutions
Quality Focused: patient safety comes first

Skills/Experience

B.S. or master degree in mechanical engineering, biomedical engineering, or related disciplines
Minimumfive 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
Experience designing with Nitinol for Class III implant devices is a significant advantage

For further information please contact James Cassidy [email protected] or call in confidence 086 0204322

The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned from time to time.

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Senior R&D Engineer