Important international company is looking for an Engineer specializing in medical devices:.
**Experience**:
4+ years of experience and demonstrated competency in validating processes/equipment and providing ongoing technical support with evidence of ongoing self-development preferred.Work experience in the Medical Device industry.
**Technical/Functional Skills**
Knowledge of the manufacturing processes of Medical Equipment
- GMP (Good Manufacturing Practices) and ISO (International Organization for Standardization) 9000 and regulatory affairs
- Ability to specify and qualify assembly equipment, tools, measuring equipment and accessories.
- Knowledge in the areas of Process Validation, Statistical Process Control, Product Design and DFMA (Design for Manufacturing and Assembly)
, Plastic and Metal Materials and Processing, and Applied Statistics. Knowledge of drawing software system such as AutoCAD and Solidworks.
- Demonstrated ability to interpret engineering drawings, i.e. GD&T (Geometric
Dimensioning and Tolerances)
- Knowledge of production processes.
Good oral and written communication in Spanish and English, preferably.
- Ability to work and interact with co-workers to achieve company objectives in a team environment.
- Ability to work in a stressful/fast-paced environment.
**Required Experience**
Demonstrated knowledge of manufacturing principles, practices and procedures.
- BWI or Johnson & Johnson experience preferred.
- Work experience in the medical device industrie
**Roles and responsibilities**:
Pursuant to (e.g., limited supervision, general direction, etc.) and in accordance with all applicable federal, state and local laws/regulations and Johnson & Johnson corporate procedures and guidelines, this position:
- Conduct meetings to develop strategies and solutions with a cross-functional team.
- May guide the Validation process, lead the writing and review of test protocols and reports.
- Can offer on-site support during the validation execution phase (IQ, OQ, PQ). Can write a validation strategy, including TMV.
- May qualify first items, complete process capability studies and process validation on both internal and supplier processes using appropriate statistical techniques
- Can support change management activities using the organization's PLM tool
- Prepare reports as per project requirements
- May supervise, coordinate and technically review the work of a limited group of technicians
- Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources necessary to do so are available and in good condition
- Responsible for communicating business-related issues or opportunities to the next level of management
- Responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies and procedures.
- Performs other assigned duties as needed
**Generic Management Skills**
Project management experience
Must have very good verbal and written communication skills.
**Academic training**
- Engineering is required in any specialty
**Location**: Costa Rica, San José
Tipo de puesto: Tiempo completo
Experiência:
- Medical products: 4 años (Obligatorio)
