Back to Job Search

Senior R&D Engineer

  • Sector: Medical Devices
  • Contact Email: amy.newell@collinsmcnicholas.ie
  • Job Ref: 18783

An exciting opportunity has arisen for an experienced Senior R&D Engineer to join a leading, multi-national medical device company in Galway on a permanent basis. The successful applicant will gain extensive exposure to both the product and the wider team, working cross functionally to develop life changing, structural heart products.


As a Senior R&D Engineer, you will be a highly experienced professional in engineering development and have extensive engineering knowledge and skills. You will be a dynamic team player and will work cross functionally with a variety of teams.


Responsibilities:


  • 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. 
  • Ieract frequently with all departments within organization and occasionally with external physicians, consultants, and vendors.
  • Minimum travel requirement of 10%.

Requirements:


  • Bachelor’s Degree in Engineering (Materials, Mechanical or Biomedical).
  • 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) is essential.
  • 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 a more detailed and confidential discussion on this role contact Amy Newell.

amy.newell@collinsmcnicholas.ie

091-706718