Product & Process Engineer Specialist

Job Description The R&D Engineer is responsible for executing scientific and engineering activities related to the development and sustaining of IVF media products. The role focuses on experimental execution, data analysis, technical problem-solving, and change control, contributing to product performance, robustness, and compliance. The position works cross-functionally to support the translation of scientific concepts into practical, scalable solutions for assisted reproductive technologies (ART), while building technical expertise in media formulation and product development. Responsibilities Support design, development, validation, and manufacturing of media products. Design and execute experiments using established scientific and statistical principles. Conduct data analysis, interpret results, and document findings effectively. Support scale-up, process development, and technology transfer activities. Perform chemical and engineering analysis of current and new media formulations. Execute prototype preparation, formulation batches, and lab-scale studies. Collaborate with cross-functional teams (Quality, Regulatory, Manufacturing, Marketing) to support sustaining and lifecycle activities. Support sustaining activities including product improvements, change management, and troubleshooting. Ensure compliance with applicable regulatory and quality standards (GMP, ISO). Maintain accurate and complete technical documentation in compliance with design control requirements. Support the creation, update, and maintenance of Design History Files (DHFs) to ensure alignment with product development and sustaining activities. Contribute to project execution under guidance of senior technical staff. Qualifications Foundational understanding of cell culture, biochemistry, or related life sciences. Knowledge of IVF/ART media development is desirable. Understanding of solution chemistry (pH, buffers, molarity, osmolality). Familiarity with GMP, ISO, regulatory requirements and regulated environments. Strong analytical and problem-solving skills. Hands-on laboratory and experimental experience. Well organized with attention to detail. Ability to follow protocols, document work accurately, and manage multiple tasks. Good organizational and time-management skills. Effective communication and teamwork skills. Benefits As an employee of CooperSurgical, you’ll receive an outstanding total compensation plan, including medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and other perks and benefits. Equal Employment Opportunity We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. If you are interested in applying and require special assistance or accommodations due to a disability, please contact View email address on click.appcast.io. #J-18808-Ljbffr CooperSurgical