R & D Engineer - Medical Devices

Job Details

R&D Engineer

Department:Engineering

Reports to:Engineering Manager

General Description
The R&D Engineer will design, develop, modify and evaluate medical devices in accordance with relevant FDA/BSI and ISO standards. Use structured engineering and statistical techniques to design new products and develop new and existing products and processes whilst adhering to regulatory requirements, project deadlines and product costs

Job Description: Role & Responsibilities

Analyze catheter architecture and related mechanical designs & design requirements
Design and set-up experiments, manage evaluation testing and work with suppliers/manufacturers in developing new and existing products
Actively involved in specifying, sourcing, testing and approving material
Prepare and lead critical technical design reviews, including preparation and presentation of supporting design documents
Project manage transfer of products from concept/design phase to commercial manufacturing
Create and maintain design-related technical notes (notebooks, protocols, validations, manufacturing documents, etc.)
Building a complete design history file
Compile and analyse operational, test and development data to establish performance standards for newly
designed or modified products
Manage and prepare engineering test protocols and reports
Provide design concepts
Work closely with manufacturing engineers to continually develop processes in relation to yield, overheads and labour efficiency

Qualifications and Education Requirements

Qualified to degree level in engineering, science or related discipline
Knowledge in the use of a variety of materials (plastics, metal, adhesives, etc.)
Knowledge of catheter manufacturing processes (bonding, moulding, etc.) is essential
Experience in bringing a product from concept/design phase to commercial manufacturing
Understanding/working knowledge of relevant FDA/BSI standards and regulatory requirements
Significant experience with design control and ISO13485
Strong project management and leadership skills essential
Experience in risk assessment and FMEA
Six sigma green belt experience
Good working knowledge in statistical process control and capability analysis using DMAIC and DOE techniques
Strong computer Skills in MS Word, Excel, Outlook, Project, etc.
CAD and Solidworks experience preferable
Excellent leadership and team management abilities, coupled with a high level of communication and interpersonal skills
Influential team member, fully motivated to achieve and demonstrate best practices in line with the department company objectives


PLEASE FORWARD CV TO CHRISTYO@HEADHUNT.IE OR TELEPHONE 00 353 87 9473404 REGARDING ANY ENQUIRIES

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