Embryologist Scientist

Cooper Surgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of Cooper Companies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond.

We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at  .

Scope:

The Embryologist Scientist serves as a scientific subject matter expert responsible for the biological evaluation and advancement of bioassay systems used to assess the safety, efficacy, and performance of assisted reproductive technology (ART) media, consumables, and devices. The scope of this role spans research, assay development, validation, and method transfer, functioning as a critical interface between Research & Development, Quality Control, and Quality Assurance.

The position has direct influence on biological risk assessment, regulatory readiness, product lifecycle decisions, and continuous improvement initiatives. Operating within a regulated laboratory environment, the role supports compliance with ISO 17025, GLP, and applicable GMP principles, and plays a key role in scientific investigations, OOS resolution, assay robustness, and next-generation bioassay development. The work performed within this scope directly impacts product quality, regulatory compliance, and patient outcomes in assisted reproduction.

Job Summary:

The Embryologist Scientist is responsible for the design, development, optimization, validation, and scientific troubleshooting of biological assays, including Mouse Embryo Assays (MEA) and sperm function assays, used to support ART product development and quality monitoring. This role conducts hands‑on laboratory experimentation, performs statistical and biological data analysis, and leads scientific investigations related to assay performance, media failures, environmental influences, and OOS/OOT events.

The scientist develops and validates new methods, establishes positive control systems, and transfers qualified assays into routine Quality Control use, including training and ongoing support.

The position collaborates closely with QC, QA, Manufacturing, and external partners, contributing technical expertise to CAPAs, deviations, validations, and continuous improvement initiatives, while advancing innovative bioassay strategies to support current and future ART technologies.

• Conduct a variety of cell‑based bioassays (MEA, Sperm motility and survivability assays and Bacterial Endotoxin Test) for research and root cause analysis testing for products utilized in human assisted reproductive laboratories
• Establishment and validation of medical device extraction methods following ISO 10933 methods
• Improve assay sensitivity, robustness and reproducibility through endpoint selection, exposure modes, dose‑response systems
• Develop and validate positive control systems (e.g., embryotoxic gradients, stress models)
• Evaluate emerging technologies and methodologies for embryo culture and reproductive testing
• Support development of next‑generation biological safety assays
• Lead and execute assay validation activities, aligned with IQ/OP/PQ principes where applicable
• Author validation protocols, risk assessments and final reports in alignment with ISO 17026 and GLP principles
• Conduct inter‑laboratory comparison and method equivalency studies
• Transfer validated methods into QC laboratories and provide technical training, ongoing assay support and troubleshooting guidance
• Lead scientific investigations related to OOS and OOT results (e.g., MEA failures), media performance issues and environmental or system impacts (e.g., incubator performance)
• Apply structured root‑cause…