Senior Product Development Scientist

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

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At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ®–– one of the first multiplexing and multimodality automated testing platforms––are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.

SENIOR PRODUCT DEVELOPMENT SCIENTIST

We are recruiting a Senior Product Development Scientist to join our Alba Product Development & Support team based at our ARC site near Penicuik, EH26 0BF. This role is a full-time, permanent position working 37.5 hours per week. Monday-Friday.

The role of our Senior Product Development Scientist is to lead, co-ordinate, supervise and undertake Design and Development projects in the Product Development department of AliveDx (formerly Quotient). To record, analyse and reach valid conclusions for complex investigations in consultation with the Principal Scientist and Department Leader, enabling the completion of projects to the agreed timelines and the highest possible standard.

JOB DESCRIPTION

The main responsibilities will include:

• To lead the planning and organising of key work packages enabling the completion of design and development projects to agreed timelines.
• To independently execute testing to an agreed schedule and to the highest possible standard.
• To record, analyse and reach valid conclusions for complex technical investigations in consultation with the Department Leader.
• Presenting technical data to internal and external stakeholders to support project and programme progression.
• Responsible for meeting Design Control requirements through project documentation and technical files with support from Project Management.
• Lead the 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.

QUALIFICATIONS, EXPERIENCE & BEHAVIOURS REQUIRED

• 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.
• Relevant experience in an appropriately regulated environment (e.g. medical devices, IVD).
• 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.
• Excellent attention to detail.
• Data analysis and interpretation skills.

ADDITIONAL INFORMATION

Competitive salary on offer.

AliveDx offers a range of core and flexible benefits ranging from private medical cover, life assurance, cycle to work, technology, and restaurant discounts.

Able to travel from time to time with prior agreement.