Senior R&D Engineer

HERO

Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Ciaran Fahy
email Connect@hero.ie

Senior R&D Engineer

Apply Now

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.

The main purpose of this job is to support the research and development of peripheral vascular products.  The employee will be a member of multiple projects through different stages of the product development cycle, bringing products to commercialization.   This employee will need to take an active leadership on the team and will mentor other engineers throughout the product development process.

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 Ciaran Fahy on 087-4108620 or connect@hero.ie

Ciaran Fahy

JOB-12236

Apply Now

Senior R&D Engineer

Ciaran Fahy

Role Type Permanent
Contact Ciaran Fahy
email Connect@hero.ie
mobile +353 87 410 86 20
linkedIn profile click here

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