**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 completo
Experiência:
- Medical Device Industry: 3 años (Obligatorio)
Idioma:
- Inglés (Obligatorio)