Main Purpose of Job:

• This position need to develop and execute the preventive and corrective maintenance of the Manufacturing
• and Facilities equipment in the site as well as coordinate with the Facilities/Maintenance Manager the design, planning, construction and maintenance of equipment, machinery, buildings and other facilities. In addition, this position needs to coordinate and supervise the technician’s performance.
• The Facilities and Maintenance Engineer must control and fill out official documentation regarding the department function and support the new products and process introduction into the plant.
• It is required to manage properly the regulatory documentation and follow them without exception. This person needs to be a model for the rest of the people about to follow procedures and improve them.

Main Job Duties/Responsibilities

• Follow an implement all personal and manufacturing Good Manufacturing Practices (GMP’s) as defined my Viant’s practices, policies and Standard Operating Procedures (SOP’s) to insure that FDA regulations are met.
• Control, evaluate and improve the preventive maintenance tasks in order to have a high reliability of the equipment/building operation according with regulations.
• Provide supervision and guidance to the Facilities and Maintenance Technicians to ensure the proper operation of all buildings and cleanrooms in the Costa Rica location.
• Participated actively to achieve the goals and objectives of the department and the plant.
• Analyzed and resolve the operational excursions, NCE’s, CAPA´s and other exceptions documents in the department.
• Additional functions may be to manage some contractors and consultants. This position need to have the capacity to lead projects and implement them.
• Ensure life/safety systems are operable at all times. This includes but not limited to, sprinkler system, smoke and fire detection system, fire extinguishers, signage, and evacuation plans as well as fire prevention.
• This Engineer needs to be a model at the EHS program implementation in all the activities.
• Review and apply all regulations applicable to the CR site according with the operations of the facilities systems (FDA, ISO,CR laws, etc.)
• Lead or participate actively in the continuous improvement teams of the operation.
• Establish with the Facilities/Maintenance Manager some indicators of facilities and manufacturing equipment operation and follow positive results of them
• Analyze, propose and implement the plan to improve continuously the operation of facilities and maintenance equipment.
• Develop and find new suppliers and contractors to help in the normal Facilities and manufacturing equipment operation
• Responsible to lead the spare parts definition, inventory and coordinate that in the plant there are the necessary quantity of them
• Perform project management responsibilities for assigned maintenance changes or new product launch.
• Keep good relationship with Production, Quality and Supply chain people in order to provide the fluency in the business process.
• Recommend new tools and methodologies including costing and cost estimates for design or product process changes.
• Develop or revise technical documentation to specify maintenance and facilities processes; including documentation of equipment qualification, setup and maintenance procedure.
• Conduct, research and development testing and validation to determine effectiveness and compliance to quality standards for the manufacturing processes. Confirm conformance to engineering designs and methodologies and verify overall safety. Prepare reports on these activities.
• Negotiate and place orders with Vention’s vendors. Maintain a positive and healthy relation with vendors avoiding conflict of interest. This person must focus on problem solving with vendors and may recommend termination or continuity of vendor.
• Be art of a development process by attending conferences, taking courses and continuing education programs to maintain or improve knowledge and practices relevant to medical device manufacturing.
• Provide drafting or design drawings to support manufacturing processes recommendations.
• Perform other duties as assigned.

Knowledge / Education

• Requires at least bachelor degree (College degree) in Mechanical, electrical or electromechanical
• engineering). It could be another engineering position with a vast experience in the field.
• Necessary to have experience as Facilities Engineer or Maintenance Engineer for at least 2 years, will be a plus in medical company
• Must be bilingual (Asdvance level of Spanish and English).
• Knowledge on ISO 13485:2003 y CFR 820 CGMPs
• Knowledge on computers packages and not limited to Autocad and Project Management Problem solving preparation

Work Experience

• Desirable demonstrated knowledge and understanding of GMPs, FDA regulations, Quality System
• Regulations (QSR), ISO 13485 requirements..
• Knowledge and experience as a Leader of technicians
• Knowledge in EHS field
• Knowledge about project management

Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on Linked In.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.