R&D ENGINEER I/II (PI) – CONTRACT (12 MONTH)

Contract (12 months) 
Location: Galway

R&D Engineer - PI:
Our clients products and technologies are used to diagnose or treat a wide range of medical conditions. They continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. Within Peripheral Interventions (PI) we design, develop, and produce technologies for treating peripheral venous and arterial disorders in addition to supporting evolving regulatory and standard requirements around product design.   The Galway PI R&D group provide design support to commercial products including Self-Expanding Stents (SES), Drug Eluting Stents (DES) and Drug Eluting Balloons (DEB). Within this role, the successful candidate would primarily be supporting post commercial activities for a Drug Eluting Stent product ensuring safety, compliance, and manufacturing continuity.

Job Purpose:  
Maintain products of moderate complexity. Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish/verify performance standards for modified products, processes, and materials and creates/maintains design-related technical documents building a complete design history.

Key Responsibilities:

• R&D support for project activities including Shelf-Life Extension Studies, Ideal Product Flow, Material Changes & other manufacturing continuity & compliance initiatives.
• Use of design change process to ensure proposed changes are systematically and thoroughly analyzed before beginning the change process. Whenever product changes are proposed, justification is written or data is collected to verify that the design intent is still met.
• Works cross-functionally with project management, quality, manufacturing, regulatory, clinical and marketing to ensure project success.
• Work collaboratively with manufacturing to ensure alignment between print requirements and process validations.
• Demonstrates design control knowledge through generation of high quality deliverables.
• Maintains product performance through Quality Investigations and ensuring rigorous support for design changes.
• Works independently to plan and schedule own activities necessary to meet timelines.
• Designs and coordinates standard engineering tests and experiments, as required.
• Performs troubleshooting on products/process problems as related to design, material or process.
• Summarizes, analyzes and draws conclusions from test results.
• Prepares standard reports/documentation to communicate results to technical community.
• Responsible for engineering documentation.
• May train and/or provide work direction to technicians and interns.
• Must be able to provide technical guidance within a team and be an effective communicator within a multidisciplinary and international organisation.
• Applies the Product Development Process (PDP) methodologies.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Qualifications & Experience:

• Primary Degree in a Science or Engineering
• Min. FETAC level 8.
• Proven ability to work within a regulated industry environment and with a track record of accomplishments. 
• Experience in a post-commercial R&D role is beneficial.
• Experience with Design Control and Design Change is necessary.
• Experience with post-commercial product support is an advantage.
• Experience with Drug Eluting Stents and coatings is a strong advantage.
• Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.
• Self-Starter with the ability to work independently to plan, schedule and execute activities necessary to meet project timelines to schedule.
• Excellent interpersonal and communication skills with good leadership abilities.
• Excellent analytical and problem-solving skills.

For more information on this role please contact Emma Griffin on 086 0334325/quality@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.