Company Description
IVFmicro is a pioneering fertility technology company developing the first oil-free microfluidic device for embryo culture in IVF. Our innovation simplifies embryo handling, standardises culture conditions, and improves consistency across clinics, aiming to make IVF more effective, accessible, and patient-focused. Supported by Innovate UK funding, we are building a dynamic, interdisciplinary team of scientists, engineers, and clinical experts to bring this breakthrough device from bench to clinic.
Role
The Research Embryologist will contribute to the final design, testing, and technical validation of the IVFmicro device, working closely with biomedical engineers, clinical embryologists, manufacturers, and regulatory specialists. The position involves hands-on prototype testing, design optimization, and preparation of verification and validation (V&V) reports to meet ISO 13485, FDA, and UKCA/CE regulatory requirements.
You will be based within the collaborative environment of Nexus and the University of Leeds facilities, and will access the specialist IVFmicro research laboratory facilities within the LIGHT Laboratories in The Leeds Institute of Cardiovascular and Metabolic Medicine.
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Key Responsibilities
• Support all aspects of preclinical testing, design validation work and laboratory data collection and analysis for the IVFmicro device and associated accessories working with embryologists, and using mouse, bovine, ovine, and human embryo models, as required at the University of Leeds.
• Support the final design and development of the IVFmicro device and associated accessories, ensuring compliance with quality and usability requirements.
• Develop and execute testing protocols to evaluate product efficacy and gamete and embryo quality
• Support translation of clinical end user feedback into engineering design specifications and design improvements.
• Collaborate with the Scientific Director and R&D Director to provide input into prototype fabrication and batch testing.
• Prepare and maintain technical documentation, including design history files (DHF), design input/output traceability, and risk analyses under ISO 14971 as well as reporting in aligned to ethical approvals and HFEA research licences.
• Work closely with the QMS and Regulatory Manager to support documentation for FDA pre-submission and MHRA/CE marking.
• Contribute to design reviews, verification reports, and documentation for the Critical Design Review milestone.
• Participate in cross-functional meetings with the Health Innovation Network and IVF clinics as appropriate to ensure clinical usability alignment.
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Essential Qualifications and Experience
• Degree (BSc or MBChB) in biomedical science or medicine (or equivalent)
• PhD in reproductive/developmental biology, physiology or other relevant discipline
• Hands- on experience of assisted reproductive technologies including oocyte harvest, IVM, sperm preparation, IVF, ICSI, embryo culture, embryo grading, timelapse imaging and morphokinetic analysis, and embryo vitrification, as applied to animal and human gametes and embryos.
• Proven experience of analysing and interpreting data and evaluating methods and results obtained.
• Strong documentation, data analysis presentation and technical writing skills (e.g., SOPs, statistics, graphics) for experimental report writing.
• Experience of working to SOPs and conducting or troubleshooting experiments in a timely manner
• Excellent interpersonal skills including ability to work effectively within a team.
• Good time management and planning skills, with the ability to meet tight deadlines, manage competing demands and work effectively under pressure without close support.
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Desirable Skills
• Experience of different embryo culture systems as used for the growth of large animal and human embryos.
• Experience of metabolism assays and single cell molecular analysis of gametes and embryos
• Experience of clinical embryology service delivery.
• Knowledge of ISO standards and HFEA regulatory frameworks and reporting requirements.
• Experience working within Agile or multidisciplinary R&D teams.
• Excellent communication and collaboration skills across biological sciences, and clinical disciplines.
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What We Offer
• Opportunity to contribute to the development of a medical device with impact on fertility outcomes globally.
• Collaborative environment across industry, academia, and clinical partners.
• Training and mentoring from leaders in microfluidics, IVF, and medtech commercialization.
• Participation in international scientific and commercial conferences for user and customer interaction and marketing.