Senior R&D Engineer (Medical Device) - Co. Galway.

You will provide leadership, support and guidance to the R&D project teams tasked with the development of new medical device products in compliance with applicable regulations including EU and FDA regulations. The Senior R&D will take responsibility for several projects through the design cycle and interface with the customer.

Key Responsibilities:

• Provides technical leadership/ support to the R&D project teams in the development and subsequent commercialisation of PTA balloons.
• Oversees the development of products and corresponding processes which meet customer requirements throughout the design phase.
• Defines capacity and resource requirements, including the recruitment, mentoring and development of the R&D Team to meet the ramp-up requirements.
• Manages a small team of Engineers and Technicians within the R&D Group.
• Mentor / Support Engineers through the design cycle requirements.
• Liaises with Business Development, Physicians, Manufacturing & Quality to ensure that the transition of products through R&D, product approval and manufacturing scale-up are smooth, timely and cost effective.
• Supports & facilitates customer correspondence for several key projects.
• Develops and implements programs in conjunction with Manufacturing Engineering, Operations and Quality Functions which drive a continuous improvement approach in the design for manufacture effectiveness.
• Manages development projects in compliance with approved procedures and in adherence to ISO and FDA regulations.

Skills and Competencies Sought:

• Demonstrable detailed working knowledge of, and expertise in, the medical device industry.
• A thorough knowledge of design life cycles requirements.
• Ability to manage a high performing team to achieve desired outcomes.
• Creative, continually stimulate your team to learn and explore new ideas.
• A strong team player who builds and cultivates a winning culture though the team.
• A good communicator who can easily convey ideas and requirements across all levels in the organisation.
• Is comfortable and confident in presenting to customers or other external bodies.
• Capacity to make sound judgements relating to the effective management of the company’s resources.
• Has a strong understanding and application of project management tools.
• Effective knowledge of the regulatory environment in which the business operates.
• Attention to detail while maintaining awareness of longer-term objectives.
• Strong interpersonal skills, a demonstrated ability to influence peers.