As a member of the R&D team, the successful candidate will assist the R&D Project Management team in the production and control of defibrillator product documentation in line with the Company’s Quality Management System and medical device regulatory requirements. The successful applicant may also be required to assist in the completion of additional project tasks as required by the Project Management team. Training will be offered to ensure that the successful applicant has all the necessary skills to complete the role.
Key Areas of Responsibility
- To assist in the composition and development of Research and Development technical documentation as identified by the project management team. This documentation may include requirements documentation, design, verification and validation documentation,
- To assist in the composition of production and quality documentation as required. This documentation may include standard operating procedures (SOP’s), work instructions, Bills of materials.
- To assist in reviewing, editing and checking documentation for accuracy, consistency and traceability from customer requirements through the company’s design lifecycle to test execution.
- To assist in creating and maintaining user manuals and instruction booklets for print and online publication
- To assist with the preparation of documentation for medical device regulatory submissions
- To assist in the identification of documentation discrepancies
- To assist in the maintenance of a traceability matrix
- To attend and contribute to Product Life Cycle Design Review Meetings
Qualifications Knowledge Skills
Applicants should be studying for a third level qualification in either design engineering, electronics, biomedical engineering or a related discipline.
- Effective written & verbal, reporting and communication skills
- Working within a team environment
- Previous experience within an engineering function
- Project leadership experience
- System/Computer Requirements:
Microsoft Office applications
- Key Competencies needed for this position?
Very high work standards with excellent attention to detail
Motivation, Negotiation and Leadership skills
Ability to adapt quickly to problems arising
Good problem solving and analytical skills
Planning and organizational skills
Must be able to work under pressure and to tight deadlines
Work From Home: Not available
Travel Percentage: None