**Vacancy Name** Senior Product Development Engineer **Location of Work** Tijuana, Mexico **Employment Type** Full Time Employee **Job Description** Lead and coordinate new product development projects, managing engineering and technical teams to ensure adherence to work plans and committed deadlines. Oversee design, validation, and introduction of new manufacturing processes and methods, ensuring products comply with regulatory and quality standards specific to the medical industry, while driving innovation, efficiency, and operational excellence at every project stage. * Develop project plans, implementation schedules, and cost estimates for internal and OEM customer projects. * Manage projects and coordinate activities for new product development. * Communicate and coordinate actions with internal departments and customers to ensure project progress, report delays, and propose solutions. * Lead process re-engineering and improvement initiatives, providing strategic guidance on designing and implementing efficient processes. * Participate in defining goals, policies, and procedures, evaluating program effectiveness and proposing improvements. * Regularly report project status to management and request approvals when necessary. * Define tasks and resources, and manage project teams; serve as the liaison between manufacturing and new product engineering. * Analyze process issues and coordinate implementation of improvements with supervision and engineering. * Implement new equipment, tools, and manufacturing processes, coordinating changes with involved departments. * Provide technical support to other departments regarding manufacturing processes. * Supervise first production runs of new products and conduct performance testing per requirements. * Evaluate processes, quality, and efficiency, potentially participating in special machinery design alongside Engineering. * Advise and support the Quality Department on equipment capability and resolution of customer complaints. * Solid knowledge of product design, validation, and transfer-to-manufacturing processes. * Proficiency in quality systems and applicable regulations (FDA, ISO 13485, GMP). * Project, schedule, resource, and budget management. * Leadership of cross-functional teams (engineering, quality, manufacturing, suppliers). * Ability to make technical and strategic decisions. * Proficiency in engineering and computer tools (advanced Excel, PLM systems, technical documentation). * Experience interacting with international customers and corporate entities. * Knowledge of risk management (DFMEA/PFMEA), APQP, and validations. * Participation in regulatory audits and new product launches. * Bachelor’s degree in Engineering or related field. * Minimum 6 years of relevant experience preferred. * Advanced English proficiency