Mauricio Hervella, MSc, PMP, SSBB

CSSBB with on-going improvement projects.

Product Quality Engineer at Flex

MSc dissertation project: The design, testing and optimisation of Thromboembolic deterrent stockings (TEDs).

Master on Science in Engineering and Management of Manufacturing Systems at Cranfield University, UK.

MSc dissertation in the optimisation of clinical trials

Medical segment. Key responsibilities: • Created and actively participated in new projects developments, from quotation and feasibility towards to validation and mass production. • Monitored, controlled and managed of CAPAs and KOIs (FPY, RTY, TML, scrap rates). • Spearheaded groups of quality technicians and inspectors, providing training sessions and directed administrative duties, records and performance management. • Led a 5-member team to launch new product lines and international project transfers (US-CAN-MEX) with projected annual sales of $120MM under strict time constraints through accelerated product development. • Constructed solid and concise quality documentation, based on FDA and ISO13485 standards, such as quality plans, risk analysis, control plans, reaction plans and SPC strategies. • Experience in clean room validation strategies (ISO14644) • Presented project status and results to customers and high-level management. • Achieved a customer satisfaction score card level of 5/5 during 2 consecutive years. • Conducted both external and internal audits, including “Mock audits” (FDA). • Supervised and verification of proper validation processes (IQ, Software validation, OQ, PQ) • Designed, run and analysed statistical studies such as stuck / tolerance analysis, correlation analysis, DOE, MSA, among others. • Identified resources needed and assigned individual responsibilities to the projects assigned.

Medical, NPI Key responsibilities: • Conducted cost analysis (Analysis of multiple trade-off scenarios). • Carry through validation processes (IQ, Software validation, OQ, PQ) for the development of manufacturing lines for medical devices, based on regulation authorities. • Troubleshoot manufacturing process issues related to product quality. • Participated in improvement initiatives (Kaizens) such as KTE Implementation (designed a method to supply raw materials in exacted kits from warehouse towards to Final Assembly line), Line balance (Micro activities concept) and Reducing WIP levels (Little’s Law concept). • Provided training for manufacturing operators, interns and new hires, ensured every operator developed appropriate skills and knowledge to executed functions properly. • Failure mode analysis and CTQ identification. • Devised manufacturing lines design to optimise space and unnecessary movements, applying lean concepts, value stream mapping and models mix. • Developed manufacturing plans (Flow Charts, Lay outs, PFMEAs, MPIs) for 12 different products. • Coordinated international projects between US (Dallas, Cincinnati) and Mexico sites, designing the manufacturing strategy of a high complex laparoscopic device. • Managed and executed ECO/ERO, ensuring product traceability and maintaining appropriated records. • Design for manufacturing approach, worked closely with customer R&D development department and suggesting new and optimum design features, product specifications and Functional Tests. • Project management activities such as Design of project plans (Microsoft Project), tracking lists, head counting analysis, among others. • Supported supplier’s qualification process (FDA and internal approval).

Non-conforming material disposition. • Analysed non-conforming material, subassemblies and final product to reduce scrap rates and provide feedback to materials suppliers. • Conceptualized, maintained and improved manufacturing methods and operations, to optimise standard times. • Assisted measuring standard, takt and set up times, to calculate required manpower based on monthly forecasts. •Manufacturing process instructions development. •Functional tests. •Dimensional analysis. •SMKT implementation (supply chain).

An established course developing professionals with a thorough understanding of the processes, skills and behaviours needed to create and manage competitive manufacturing operations. It majors on industrially relevant projects, team working, and transferable skills, which allow students to enjoy careers in a wide range of sectors from financial services through to health care.

Statistical Industrial Engineering