Technical/Functional Skills Knowledge of statistical software packages such as Minitab a plus. Process Excellence tools such as Lean and Six Sigma certification a plus. Knowledge of drawing software system such as AutoCAD and Solidworks. Business/financial acumen Knowledge of productive processes. Good oral and written communication in Spanish and English, preferably. Ability to work and interact with co-workers to accomplish company goals in a team environmentRoles & ResponsibilitiesUnder (e.g. limited supervision, general direction, etc.) and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Can guide the EM on the Validation process, lead the draft and review of protocols and test reports Can offer onsite support at the EM during the execution phase of validations (IQ, OQ, PQ). Can draft Validation Strategy, including TMV's Need to determine approach to documentation to be transferred - systems, flows, storage, etc. Should review current DHF status for products in scope. Can identify needed strategies and inputs from R&D & other functions. Plan and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria while devising new approaches to problems encountered Plan, schedule, conduct, and coordinate detailed phases of engineering work in part of a major project or in a total project of moderate scope that involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of conventional materials, and difficult coordination requirements. Update work instructions, part specifications, validation protocols, technical documents (PFMEA's, ECOs, NCR's, CAPA's), and various forms of reports and correspondence. Can supervise, coordinate and technically revise the work of a limited group of technicians. Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition Responsible for communicating business related issues or opportunities to next management level Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed Ability to work in stressful/fast paced environment**Requisitos**:Experience Required3+ in Years in Medical Device IndustryProject Management experienceMust have very good written and verbal communication skill.Project Management SkillsDemonstrated knowledge of manufacturing principles and practices, and proceduresExperience in New Product Development for Medical Device IndustryExperience in Technical documentation, quality control, lay-out, fabrication, modification, and assembly of mechanical or electrical equipment and/or components for Medical-DeviceEducation An Engineering in any specialty is required Master's in Science is recommended English AdvancedBeneficiosLaw BenefitsCompetitive SalaryCourses and Certifications**LOCATION**: San José, Costa Rica
