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Job ID: JOB-12236
Senior R&D Engineer

Ready to join one of the truly great companies in Ireland? We have a really exciting job opportunity for a Senior R&D Engineer based in Galway. Join a super team of people and a company that offers exceptional salaries and rewards. Let’s have a conversation to find out more about what’s important to you.

A DAY IN THE LIFE OF:
•    Lead the development (design and process) of PTA balloons in the Peripheral Vascular space.
•    Assist in the development of new combination products and components. 
•    Prototype, test, and iterate designs used in the medical field.
•    Leading teams of design engineers during development of products.
•    Support the development and integration of new technologies into the Cardiovascular product offering. 
•    Provide assistance to interdepartmental team for new product introduction. 
•    Take an active role in early-stage design control activities leading to a first in man study (innovation, proof of principle, product development, process development, and equipment development) such that a robust pilot line that is scalable and transferable to commercial manufacturing is achievable. 
•    Document research and development process through lab notebooks, engineering characterization studies, and test reports. 
•    Work with Regulatory Affairs (RA) to compile US and OUS regulatory submissions.  Assist RA with answering subsequent questions from regulatory bodies. 
•    Design and develop new test methods and equipment specific to new products.  Train technicians in new processes. 
•    Create document change orders (CO’s) for design, materials, and process documentation. 
•    Work with Regulatory, Preclinical, Quality, and Manufacturing departments to create product performance, design, and manufacturing specifications. 
•    Perform competitive product analyses. 
•    Work with patent counsel to file and evaluate intellectual property. 
•    Interact frequently with all departments within organization and occasionally with external physicians, consultants, and vendors.
•    Minimum travel requirement of 10%.
 
Qualifications:

• Bachelor’s Degree in Engineering (Materials, Mechanical or Biomedical).
• Master’s degree.
• 6+ years working in R&D, Quality and/r Manufacturing on combination medical devices.
• Experience with test method validation.
• Mechanically drive design experience.
• Knowledge of design of experiments (DOE) and statistical techniques.
• Proficient with SolidWorks.

Key Skills and Experience:

•    Specialized knowledge in PTA balloon design and process development (extrusion, forming).
•    Experience in R&D, Quality and/or Manufacturing in a regulated industry, working through different phases of product development.
•    Leading teams / sub teams.
•    Mentoring engineers. 
•    Prototyping mechanical systems.
•    Complete understanding and wide application of technical principles, theories, and concepts toward product, process, and technology development and evaluation. 
•    Able to provide imaginative, thorough, and practical technical solutions to a wide range of difficult problems, consistent with company’s objectives.
•    Successful collaboration as part of a cross-functional team.
•    Background demonstrating strong self-motivation; able to works under only general direction, independently determining and developing approaches to solutions. 
•    Proficient with computer applications (i.e., Word, Excel, PowerPoint, Minitab, etc.). 
•    Ability to communicate well (both written and verbal).

For more information on this Senior R&D Engineer position, get in contact with Shannon McCrossan on 086-8168273 or connect@hero.ie

Shannon McCrossan

JOB-12236

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