Daniel Esparza Rubio Email & Phone Number

Develop and manage comprehensive project plans for the planning phase of product simplification initiatives, while developing and maintaing robust data models to track project progress and key performance indicators.

Ciudad Juárez, Chihuahua, Mexico

• Lead and execute critical supplier component changes throughout the organization's supply chain, collaborating with departments including sourcing, regulatory affairs, design, materials, biocompatibility, sterilization, and quality assurance.

Ciudad Juárez, Chihuahua, Mexico

• Lead validation projects for Cordis' product families, ensuring alignment with updated European MDR (Medical Device Regulations).• Drive successful submissions to regulatory authorities by actively participating in the regulatory process.• Facilitate cross-functional collaboration to ensure seamless implementation of regulatory updates.

San Angelo, Texas Area

• Quality Engineer - Cardinal Health• Sr. Project Engineer - Biosense Webster• Sr. Validation Engineer - Cordis• Sr. MEST Engineer - Cordis

Cd. Juarez Chihuahua Mx.

• Lead production line capacity expansion for medical devices, ensuring efficiency and quality.• Manage financially-driven projects, assess costs/benefits, and ensure budget compliance.• Develop proposals to boost productivity and operational efficiency.• Drive implementation of financial engineering projects (aCAR) for financial and operational projects.• Oversee projects up to $5M, coordinating resources and timelines.• Collaborate with cross-functional teams and suppliers for successful project execution.• Conduct risk analysis, develop mitigation strategies.• Generate progress reports, present to senior management.• Continuously evaluate results, identify improvements.

Ciudad Juárez, Chihuahua, Mexico

• Offering technical expertise to Quality and Manufacturing departments.• Leading the Cordis Acquisition transfer from J&J to CAH.• Serving as the subject matter expert (SME) for validation document review and approval (Projects, Strategies, DOE, Protocols / Reports).• Guiding validation workshops and ensuring compliance with GMP & GDP guidelines during the transfer project.

Chihuahua, Mexico

• Validated medical device equipment and manufacturing processes.• Led IQ, OQ, and PQ validation efforts.• Experienced in new equipment validation and FAT execution.• Understanding in CFR-21, NOM-241, and ISO13485 regulations.• Developed and implemented a VMP database for informed decision-making.

Chihuahua, Mexico

• Collaborated with R&D on 10+ projects, contributing to their development.• Managed implementation of 100+ local and interfacility/design engineering change orders.• Designed and implemented innovative tools in partnership with suppliers.• Led corporate procedure development, driving improvements.• Supervised engineering interns and technicians.• Validated manufacturing processes for electronic medical devices.• Executed comprehensive release processes (IQ, OQ, PQ, R&R).• Addressed internal/external audits, creating effective solutions.• Assisted QA in CAPA, RMA, and NCR response.• Successfully deployed RoHS Directive conversion in electronics business unit.

Master Of Business Administration (M.B.A.), Engineering

Activities and Societies: University Student ConcilForm Masters and Specialists with skills in leadership and management, with extensive.

Engineer'S Degree, Biomedical/Medical Engineering

Activities and Societies: CGA Consejo General de Alumnos / General Council of Students TALUA Taller de Lideres Universitarios de AMIESIC /.