Development Scientist - Diagnostics
Hartmann Young is partnered with a global medical diagnostics company specialising in IVD that target autoimmune disease, allergy testing and transfusion medicine. They are going through a phase of expansion and are looking to grow their team in Edinburgh, UK, with the addition of a Haematology Development Scientist.
Role Summary:
- To assist in the planning and organising of key work packages enabling the completion of design and development projects to agreed timelines.
- To independently execute testing to the highest possible standard.
- To record, analyse and reach valid conclusions for complex technical investigations in consultation with the Department Leader.
- Responsible for meeting Design Control requirements through project documentation and technical files with support from Project Management.
- Assist with preparation and review of appropriate documentation to enable the department to comply with Regulatory requirements.
- Actively participate in project team and other group meetings as required.
- Presenting technical data to internal and external stakeholders to support project and programme progression.
- Participate in an 'in-house' programme of continuous training and assessment.
- Perform any other duties as reasonably requested from the company from time to time.
QUALIFICATIONS, EXPERIENCE & BEHAVIOURS REQUIRED
- BSc (or higher) in a relevant Life Science, Biomedical Science, or related discipline.
- Clinical haematology or immunohaematology laboratory experience, with a practical understanding of diagnostic workflows and instrument troubleshooting, is desirable.
- Relevant experience in an appropriate regulated environment (e.g. Medical devices, IVD, or pharmaceutical industry)
- Experience in IVD or medical device product development.
- Experience in recording and reporting on experimental outcomes.
- Familiarity with quality management systems and regulatory standards applicable to IVD products (e.g. ISO 13485, IVDR, 21 CFR Part 820).
- Ability to work effectively as part of a cross-functional team and communicate complex technical information clearly to a diverse stakeholder group.
- Data analysis and interpretation skills.
- Problem solving skills.
- Excellent attention to detail.
If this sounds like an opportunity of interest, please reach out or apply directly below - We'd love to hear from you!
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