Research & Development

Senior R&D Engineer

Location: Dublin

Job Purpose

The Senior R&D Engineer will provide technical leadership, project management and design input to the development of the device and will lead and guide other members of the R&D team.

Responsibilities

  • Development of medical device, including product and material specifications, material sourcing, equipment and tooling specifications and sourcing, process development and testing, to develop new products from concept to design freeze;
  • Project manage all developments to ensure that all commitments are achieved including functional prototypes, delivery dates, design iteration samples, test protocols and reports, project costs to ensure project deliverables are achieved;
  • Ensure full compliance with all Quality, Regulatory, Health and Safety and other relevant legislation;
  • Ensure full traceability of Design Development and control of changes;
  • Ensure full and effective transfer of new products after Design Freeze to manufacturing areas ensuring that the product and processes are developed to allow product/process verification/validation to begin;
  • Provide comprehensive training to manufacturing staff to ensure a smooth production start including validations and records;
  • Constantly review development processes to ensure they are effective and compliant with the goal to achieve the optimum development cycles at minimum cost;
  • Provide effective internal and external reporting. Ensure Tax credit data and reports are maintained and compiled ongoing and are available at the end of each year;
  • Train, develop and lead R&D engineers and other technical staff. Assign tasks and provide support and assistance to the development team;
  • Provide assistance and support to other departments including Manufacturing, Quality and Regulatory as required;
  • This could include major issues with newly developed products/processes, resource balancing and major priorities;
  • Engage with the FIRE1 QMS to ensure delivery of the overall quality strategy & support the achievement of the business quality objectives.

Experience & Education

Essential: Minimum Bachelor’s Degree in Engineering related discipline (Biomedical or equivalent); 6+ years previous experience in a Medical Devices environment with knowledge of medical device product development and associated manufacturing processes.

Desirable: Masters Qualification in Engineering in Biomedical or equivalent.

Skills

  • Demonstrate an analytical approach to problem solving and good attention to detail;
  • Be innovative & creative, show appetite to continually learn and explore new ideas;
  • Be a self-starter and use his/her own initiative in most situations;
  • Be a strong team player with proven capability to work well in a fast paced, dynamic environment;
  • Have strong interpersonal and communications skills;
  • Have an ability to manage multiple tasks and adapt to changing, fast paced 
  • environment;
  • High level computer skills including Solidworks, Microsoft Excel, PowerPoint and Word and MS Project.

Reporting

Reports to R&D Director / Manager

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