**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 environment**Roles & Responsibilities**Under (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 Required**- 3+ in Years in Medical Device Industry- Project Management experience- Must have very good written and verbal communication skill.- Project Management Skills- Demonstrated knowledge of manufacturing principles and practices, and procedures- Experience in New Product Development for Medical Device Industry- Experience in Technical documentation, quality control, lay-out, fabrication, modification, and assembly of mechanical or electrical equipment and/or components for Medical-Device**Education**- An Engineering in any specialty is required- Master's in Science is recommended- English Advanced**Location**:**San José, Costa Rica**Tipo de puesto: Tiempo completoExperiência:- Medical Device Industry: 3 años (Obligatorio)Idioma:- Inglés (Obligatorio)
