Ernesto Terrazas Marquez

Lead Product Transfer, Design Transfer, Process Validation, and manufacturing implementation activities for regulated medical device products within ISO 13485 and GMP environments. Collaborate with cross-functional teams to support manufacturing readiness, equipment qualification, validation execution, and successful product commercialization. • Lead Design Transfer and Product Transfer activities from development into manufacturing. • Develop and execute IQ/OQ/PQ validation protocols supporting manufacturing readiness and regulatory compliance. • Coordinate Engineering, Quality, Operations, Supply Chain, Regulatory Affairs, and R&D teams. • Support Equipment Qualification and manufacturing implementation initiatives. • Develop technical documentation including validation protocols, reports, risk assessments, engineering studies, and manufacturing specifications. • Support CAPA investigations, root cause analysis, and continuous improvement activities. • Lead manufacturing implementation activities for extrusion, injection molding, assembly, and spring wire guide manufacturing processes. • Support audit readiness and compliance activities under ISO 13485 and GMP requirements. • Executed and supported 15+ IQ/OQ/PQ validation protocols for regulated medical device manufacturing processes. • Successfully supported multiple product transfer and manufacturing implementation projects. • Led manufacturing implementation and process optimization activities for critical medical device manufacturing operations.

Supported New Product Introduction (NPI), Design Transfer, manufacturing implementation, and engineering change activities for regulated medical device products. Worked closely with R&D, Manufacturing, Quality, and Supply Chain teams to ensure successful product launches and manufacturing readiness. • Support Design Transfer and NPI projects from development through manufacturing implementation. • Manage Engineering Change Orders (ECOs) and Engineering Change Notices (ECNs). • Develop technical documentation, manufacturing specifications, and engineering reports. • Support validation planning, equipment qualification, and manufacturing process implementation. • Participate in PFMEA reviews, risk assessments, and manufacturing readiness evaluations. • Collaborate with suppliers and internal stakeholders to support technical compliance and implementation activities. • Supported multiple Design Transfer and New Product Introduction projects. • Improved manufacturing readiness through engineering changes and process optimization activities. • Supported qualification and validation activities for manufacturing equipment and production processes.

Managed Engineering Change Management activities for automotive electronic products, coordinating Engineering Change Requests (ECRs), Engineering Change Orders (ECOs), Engineering Change Notices (ECNs), and product lifecycle modifications to ensure compliance with quality, manufacturing, and customer requirements. • Coordinated engineering change processes from initiation through implementation, ensuring timely execution of approved product and process modifications. • Managed ECR, ECO, and ECN workflows, tracking status, priorities, approvals, and implementation activities across multiple functional teams. • Facilitated regular engineering review meetings to monitor project progress, engineering change execution, and milestone achievement. • Maintained APQP documentation related to engineering changes, running changes, and product lifecycle management activities. • Evaluated engineering change submissions to ensure compliance with internal procedures, customer requirements, and quality standards. • Collaborated with Engineering, Manufacturing, Quality, Supply Chain, customers, vendors, and subcontractors to support successful implementation of engineering changes. • Served as the primary plant contact for BOM updates, engineering change documentation, and change implementation activities. • Monitored engineering change metrics and backlog status, providing regular updates and visibility to stakeholders and leadership teams. • Improved visibility and tracking of engineering change activities through structured reporting and backlog management processes. • Supported successful implementation of engineering changes while maintaining compliance with customer and quality requirements. • Strengthened cross-functional coordination between Engineering, Manufacturing, Quality, and Supply Chain teams.

Led New Product Introduction activities for automotive electronic products within IATF 16949 and ISO 9001 manufacturing environments. Coordinated cross-functional teams to support product launches, manufacturing readiness, and process implementation activities. • Coordinate NPI activities from prototype through production launch. • Develop PFMEAs, Control Plans, Process Flow Diagrams, and manufacturing documentation. • Support APQP activities and manufacturing readiness reviews. • Lead structured problem-solving and root cause analysis activities. • Collaborate with suppliers and manufacturing teams to support successful product launches. • Successfully supported multiple automotive product launches. • Improved launch readiness through risk management and process planning activities.

Supported process development and manufacturing optimization activities for automotive safety systems within a German manufacturing environment. Collaborated with local and international teams to improve process capability, quality performance, and operational efficiency. • Design and optimize manufacturing processes for automotive safety products. • Develop PFMEAs, Control Plans, Work Instructions, and process documentation. • Support supplier qualification, validation, and technical compliance activities. • Lead process improvement initiatives focused on quality and manufacturing performance. • Collaborate with cross-functional teams to support production readiness and continuous improvement. • Developed process documentation and risk management tools supporting production readiness. • Improved technical compliance through supplier collaboration and process optimization. • Gained valuable experience working within German engineering and manufacturing environments.

Supported manufacturing implementation, process qualification, and continuous improvement activities for aerospace interconnect products within a highly regulated manufacturing environment. • Develop tooling, fixtures, and manufacturing support solutions. • Create process documentation, work instructions, and manufacturing specifications. • Support product transfer and manufacturing readiness activities. • Participate in process improvement and root cause analysis initiatives. • Supported successful implementation of aerospace manufacturing processes. • Improved manufacturing readiness through tooling and process optimization activities.

Supported implementation and qualification of manufacturing processes for automotive electronic components within ISO 9001 and TS 16949 regulated environments. • Develop PFMEAs, Control Plans, and manufacturing documentation. • Support process qualification and manufacturing implementation activities. • Design tooling and fixtures to improve process capability and manufacturing efficiency. • Participate in continuous improvement and structured problem-solving initiatives. • Supported successful implementation of new manufacturing processes. • Improved manufacturing consistency through process standardization and risk management activities.