Manuel Martinez

Mechatronic engineer with more than 14 years of expertise in medical device manufacturing. • Areas of expertise include Engineering and Maintenance department competencies where increased responsibilities roles have been accomplished. • Strong technical and mechanical knowledge that provide an edge when it comes to machine parameters and behavior understanding and its conversion to process validation requirements. • Key team player, dedicated, great learning potential and commitment for exceeding established goals while following applicable regulations and procedures. • Ability to work under pressure and skill to develop accurate project timelines. • Comprehension of engineering, quality, and maintenance systems as well as product costing, routing calculation and overall engineering change development processes. • Multicultural sense to build strong teamwork.

Process validation of fixtures and equipment’s IQ, OQ, PQ, PPQ within clean room. • Test method validation (TMV) in conjunction with quality team. • Validation of Process Relocation. • Generation and update of MPS (Manufacturing procedure sheet) under ECOs. • Engineering changes under ECOs. • Sustaining Engineer. • Savings project planning and development. • Presentation to management scrap and efficiency metrics (TIER III). • Generation and follow-up of actions to maintain production metrics within the specified goal. • Continuous improvement projects (Efficiency) and Scrap reduction projects. • Update BOMs. • Project presentation to staff (cost reduction and savings). • Key team player in workshop for process documentation reduction (Forms). • CAPA leader (RCA tools) • Follow-up and closure of NC, QN, NCR actions under methodology of brainstorming, RCA, 5 Whys, Ishikawa, 8Ds, A3, Etc. • Follow-up of actions with the engineering team (Projects and sustaining activities)

Mechatronic Engineer (Degree) Universidad Tecnológica de Tijuana (UTT) Baja California, México