Location: Dublin
Job Purpose
To develop products for use in medical procedures. To provide technical support for product and process development and field related activities such as clinical programs and complaint investigations. To support the introduction/implementation of product/process/materials changes to the design/manufacturing operation.
Responsibilities
- Product and process concept generation, presentation, prototyping and development
- 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 and other project deliverables are achieved
- Ensure full compliance with all Quality, Regulatory, Health and Safety and other relevant legislation
- Ensure full and effective transfer of new products after Design Freeze to manufacturing areas ensuring that the product and processes are fully developed to allow product/process verification / validation to begin
- Provide comprehensive training to production, quality and technical staff to ensure a smooth production start including validations and records
- Train and develop interns 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
- Engage with the FIRE1 QMS to ensure delivery of the overall quality strategy & support the achievement of the business quality objectives
Experience & Education
Essential: Third level Qualification in Engineering or Science, preferably in Mechanical or Biomedical; Minimum Bachelor’s Degree in a Science / Technology / Engineering related discipline (Mechanical, Manufacturing, Automation or equivalent)
Desirable: 2-3 years previous experience in a Medical Devices environment with knowledge of medical device products and associated manufacturing processes
Skills
- Demonstrate an analytical approach to problem solving and good attention to detail
- Be 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 Microsoft Excel, PowerPoint and Word and MS Project
Reporting
Reports to Vice President R&D with dotted Reporting Line to Senior R&D Engineer
