R&D AND OPERATIONS MANAGER

About Premium FertilityAt Premium Fertility, we are committed to transforming the assisted reproductive technology by commercializing our patented technology for embryo transfer in In-Vitro Fertilization procedures. We aim to enhance our dynamic team by recruiting a skilled R&D and Operations Manager.Based in Valencia, Premium Fertility is an innovative startup that has developed an electromechanical system, classified as medical device, that automates and enhances the embryo transfer process in In-Vitro Fertilization treatments, setting new standards in the field.The successful candidate will play a pivotal role in our organization, leading the industrialization and commercial production of our system including driving ongoing improvements to the design post-market launch, ensuring the system continues to meet the highest standards of efficiency and effectiveness.Role summary:As the R&D and Operations Manager, you will play a critical role in leading the industrialization and commercial production of our Transfer Direct System. Your responsibilities will include:Enhancing system designs post-market launch.Selecting and managing the contract manufacturing partner to ensure high-quality production.Overseeing the entire production process from design transfer to market delivery.Implementing and managing after-sales support services.Key Accountabilities and Responsibilities:Provide innovative solutions in the design, development, and production of electromechanical systems (hardware and software) including translating user requirements to functional requirements and to technical solutions, following design control process according to ISO 13485 .Lead the transfer to production of the current design after finishing the on-going RFP process for selecting an external contract manufacturing partner. Perform a quality validation to ensure that the start of production is carried out without incident.Manage quality control throughout the production lifecycle to maintain high standards of product safety, efficacy, and reliability including root cause analysis to define corrective and preventive actions.Ensure compliance with all regulatory standards including ISO 13485 for medical device quality management systems, the Medical Device Regulation (MDR) for product safety and performance in the European Union, and other applicable international standards as FDA.Set up the after-sales services department to ensure customer satisfaction and product reliability post-purchase including:-Training sessions for customers to ensure optimal use of the products.-Dedicated help desks and technical support teams that provide timely assistance and troubleshooting.-User-friendly documentation and maintenance guides.-Feedback mechanisms to gather customer insights to be used to continuously improve product performance.Develop and maintain technical and administrative procedures, standards, and guidelines covering design, production and after-sales.Collaborate with cross-functional teams to jointly achieve the business objectives of Premium Fertility including the departments of Clinical Studies (providing technical support during clinical trial) and Quality Assurance & Regulatory Affairs (to obtain and maintain marketing authorization).Required skills and experience:Master of Science or equivalent in Industrial/Mechanical/Automation and Electrical Engineering or equivalent.Strong knowledge of multiple areas of industrial engineering including mechanical design, electronics, automatization and production.Knowledge of design software (CAD, SolidWorks, rhino or similar).Proven experience in:-Design control of medical devices including working with QMS and performing transfer to production.-Working with external contract manufacturing partners.-Troubleshoot equipment and system testing.-Working with cross-functional teams.Analytical, planning, and organisational skills.Innovation and creativity.Willingness to participate with innovative approaches in our projects.Business fluency in English.Other requirements:Ability to travel.A minimal of 5 years of expertise in previous similar positions.Labor conditions:A competitive salary package commensurate with your experience.Permanent contract with a dynamic and innovative company.Opportunities for professional development and growth.Workplace:Our facilities are in the Parque Tecnológico de Paterna.Application Process:If you are interested, we would appreciate it if you could send us your application to the following email address: iserra@fundacioncarlossimon.com