Support the product development of a cutting‑edge structural heart device through design development, verification, clinical trials, validation and regulatory approval. This role will focus primarily on the design and testing of the implant, delivery system and all sub‑components that interact with the valve implant. This role is based on site in Galway or Dublin R&D office .
Reporting Lines
Reports to the Head of R&D or designate.
Key Responsibilities and Duties
Working as a part of a cross‑functional team to design and develop a novel transcatheter heart repair device in line with user needs.
Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality.
Develop device specifications, in line with user needs, including generating creative solutions to problems.
Design and development at a component level, generation of detailed drawings and specifications, including peer review.
Work in SolidWorks to review, import and optimise models.
Develop models based on first principals and/or computational techniques to understand device performance in‑vivo.
Source, build and test prototypes; analyse test data and interpret to identify optimal solution.
Develop test methods for product evaluation and validation.
Prepare reports and presentations to communicate the assessments and analysis results in an easy to understand format for the understanding of others.
Drives risk management for components under their responsibility and supports a system level risk based design approach.
Generate technical documentation for the Product Design History File and Device Master Records
Ensure Quality in the product’s design for durability, usability, reliability, functionality, marketability and manufacturability.
Support clinical validation to understand performance of the device in vivo.
May support clinical cases for device preparation or physician proctoring to ensure successful translation of the device intent to the end user, and successful clinical studies.
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
Technical : Fundamental understanding and frequent application of technical principles and techniques in the development of medical devices, ideally cardiovascular devices. Knowledge of key materials and manufacturing processes
Problem Solving : Supports a culture of data‑driven problem solving and technical decisions that ensure development of high‑quality devices. This includes adherence to any systems / processes for robust data capture, analysis and presentation of technical information to guide the decision‑making process.
Innovation/ IP : Investigates & implements new ideas to contribute to companies IP portfolio through disclosures.
Project Management : Demonstrates project management & organisational skills. Ability to complete individual tasks on time and on budget. Able to effectively plan own work when provided outline assignments. Effectively communicates budget needs for development activities.
Initiative : Demonstrated ability to take initiative to prioritize work, reach business objectives and challenge task team decisions as required.
People Skills : Demonstrates people skills to work effectively with others to achieve company goals.
Communication: Effective verbal and written technical communication skills of technical information in a format appropriate for the understanding of others. Demonstrated effective presentation and group communication skills.
Education and Experience
B.S. or master’s degree in mechanical engineering, biomedical engineering, or related disciplines
Minimum of 2-3 years of Class III Structural Heart/Cardiovascular medical product development experience involving clinical trials highly preferred
Experience in Nitinol, delivery catheters, material selection, and test method development is beneficial
Strong capability of assessing in vitro and in vivo properties of device/device components including knowledge of the implant/tissue interface and challenges.
Knowledge of engineering mechanics, mechanical design, material processing, fatigues analysis, metallurgy and strength of materials.
Experience operating in a regulated environment, preferably medical devices with knowledge of Nitinol processing and properties.
Experience working with SolidWorks and CAD software. Working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
Excellent communication, organisational and time management skills
Experience of preparing technical documentation
Availability to travel is required
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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