Senior Product Development Scientist – IVD Diagnostics Leader

AliveDx; Penicuik; On-site; GBP 60,000 - 75,000; Full time

Benefits offered by this job

Private medical cover

Life assurance

Cycle to work

Restaurant discounts

Job summary

AliveDx is seeking a Senior Product Development Scientist to join the Alba Product Development & Support team at our ARC site near Penicuik, EH26 0BF. This full-time role (37.5 hours/week) is based Monday–Friday and focuses on leading design and development projects in a regulated environment.

You will record, analyse and interpret complex investigations, present data to stakeholders, and ensure compliance with Design Control and regulatory standards.

Qualifications

• BSc (or higher) in a relevant Life Science, Biomedical Science, or related discipline, Immunology qualification is desirable.
• Experience in IVD or medical device product development, including assay optimisation and design verification activities is mandatory.
• Clinical Haematology or immunohaematology laboratory experience, with a practical understanding of diagnostic workflows and instrument troubleshooting, is desirable.

Responsibilities

• Lead planning and organising key work packages to complete design and development projects on time.
• Independently execute testing to a defined schedule and to a high standard.
• Record, analyse and reach valid conclusions for complex investigations in consultation with the Department Leader.
• Present technical data to internal and external stakeholders to support project progression.
• Ensure Design Control requirements through project documentation and technical files.
• Lead preparation and review of documentation to comply with regulatory requirements.
• Participate in project team and other group meetings as required.
• Engage in an in-house program of continuous training and assessment.

Skills

Cross-functional collaboration

Data analysis

Attention to detail

Education

BSc in Life Science or related

Immunology qualification desirable

Job description

AliveDx is seeking a Senior Product Development Scientist to join the Alba Product Development & Support team at our ARC site near Penicuik, EH26 0BF. This full-time role (37.5 hours/week) is based Monday–Friday and focuses on leading design and development projects in a regulated environment.

You will record, analyse and interpret complex investigations, present data to stakeholders, and ensure compliance with Design Control and regulatory standards.