Manufacturing Engineer 3
hace 5 meses
Knowledge / Education
- Minimum education required to perform duties: Bachelor degree in Engineering (i.e. Mechanical, Manufacturing, Industrial Engineering or science related engineering discipline, etc.)
- Bilingual English/Spanish - Advanced English level (written and spoken).
- Knowledge of applicable regulations for the medical device industry (FDA CFR 820 CGMPs, ISO 13485, etc.).
- Knowledge of Six Sigma Methodology (green belt certification) and Lean Manufacturing.
- Basic knowledge of Minitab statistical software.
Job Experience
- From 2 to 4 years of experience in a manufacturing environment.
- Experience within the medical device manufacturing or pharmaceutical fields, or any other highly regulated industry (i.e. food, aerospace, etc.) is a plus.
- Project Management experience.
**Responsibilities**:
- Perform project management responsibilities for assigned tasks on new product launches.
- Create new Device Master Record and Device History Record for the assigned manufacturing areas (documentation required for manufacturing). Prepare any other applicable documentation required for new products, processes, changes and transfers.
- Develop or revise technical documentation to specify manufacturing processes; including documentation of equipment qualification, setup and maintenance procedure.
- Coordinate and carry out qualification and validation activities for new products, processes, changes and transfers as per FDA or other applicable regulations (IQs/OQs/PQs/PPQs/TMVs). Prepare validation protocols and reports for moderate and high complexity qualifications. Participates on the definition of validation strategies.
- 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.
- Develop and coordinate plant layout (not limited to the production floor and specific lines) and installation of new equipment, utilizing principles of ergonomics and equitable standards, to maximize efficiency.
- Coordinate engineering activities with different value streams.
- Coordinate negotiating and placing orders with vendors. Maintain vendor relations; problem solving with vendors; may recommend termination of vendor relations.
- Participate in sourcing of new machinery for production needs when necessary.
- Assess Engineering related procedures within the Company’s Quality System and other systems in order to implement improvements for an optimal use and allocation of resources while maintaining compliance with the regulations.
- Act as a quality system internal auditor.
- Customer service: Direct communication with external customers, handle customer technical inquiries for specific assigned projects. Lead technical meetings with external customers.
- Perform other duties, tasks, or projects at the direction of immediate supervisor and not limited to the job category.
Skills / Competencies
- Good interpersonal skills and the ability to communicate orally and in writing.
- Self-motivated.
- Organized and able to manage multiple tasks and priorities.
- Must be able to read and understand specifications. Proficient in the interpretation of technical drawings.
- Must be able to work and effectively communicate with others.
Viant proporciona igualdad de oportunidades de empleo (EEO) a todos los empleados y solicitantes de empleo sin tener en cuenta la raza, color, religión, género, orientación sexual, nacionalidad, edad, discapacidad, estado civil, amnistía, o estatus como veterano cubierto de acuerdo con las leyes federales, estatales y locales aplicables. Viant cumple con las leyes estatales y locales aplicables que rigen la no discriminación en el empleo en todos los lugares en los que la empresa tiene instalaciones.
-
Manufacturing Engineer 3
hace 5 meses
Heredia, Costa Rica Viant Medical A tiempo completoResponsibilities - Perform project management responsibilities for assigned tasks on new product launches. - Create new Device Master Record and Device History Record for the assigned manufacturing areas (documentation required for manufacturing). Prepare any other applicable documentation required for new products, processes, changes and transfers. -...
-
Manufacturing Engineer 3
hace 6 meses
Heredia, Costa Rica Viant Medical A tiempo completoKnowledge / Education - Minimum education required to perform duties: Bachelor degree in Engineering (i.e. Mechanical, Manufacturing, Industrial Engineering or science related engineering discipline, etc.) - Bilingual English/Spanish - Advanced English level (written and spoken). - Knowledge of applicable regulations for the medical device industry (FDA CFR...
-
Manufacturing Engineer Assistant
hace 6 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Main Purpose of Job**: Under the direction of Manufacturing / New Product Introduction (NPI) or other technical managerial position and depending on the incumbent´s level of knowledge and Education, he/she will assist the engineers in projects related activities such as: documents preparation, documents translations, documents handling, BOMs creation,...
-
Manufacturing Engineer Assisstant
hace 6 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Main Purpose of Job**: Under the direction of Manufacturing / New Product Introduction (NPI) or other technical managerial position and depending on the incumbent´s level of knowledge and Education, he/she will assist the engineers in projects related activities such as: documents preparation, documents translations, documents handling, BOMs creation,...
-
Molding Engineer 3
hace 5 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Job Title**: Molding Engineer 3 **Department**: Engineering - Molding and/or Extrusion Knowledge / Education - Minimum education required to perform duties: Bachelor degree in Engineering (i.e. Mechanical, Manufacturing, Industrial Engineering or science related engineering discipline, etc.) - Proficient in Microsoft Office. - Bilingual English/Spanish -...
-
Molding Engineer 3
hace 5 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Job Title**: Molding Engineer 3 **Department**: Engineering - Molding and/or Extrusion Knowledge / Education - Minimum education required to perform duties: Bachelor degree in Engineering (i.e. Mechanical, Manufacturing, Industrial Engineering or science related engineering discipline, etc.) - Proficient in Microsoft Office. - Bilingual English/Spanish -...
-
Manufacturing Engineer Intern
hace 6 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Job Title**: Manufacturing Engineer Intern **Department**: Engineering **Main Purpose of Job**: (Brief Summary) - Under the direction of the Director of Mfg Engineering or VST Manager or Designee, is responsible for the design, implementation, fixturing and methodology to support manufacturing production and efficiencies. Analyze current manufacturing...
-
Manufacturing Engineer Intern
hace 5 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Job Title**: Manufacturing Engineer Intern **Department**: Engineering - ____________________________________________ **Main Purpose of Job**: (Brief Summary) - Under the direction of the Director of Mfg Engineering or VST Manager or Designee, is responsible for the design, implementation, fixturing and methodology to support manufacturing production and...
-
Manufacturing Engineer I
hace 6 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Job Title**: Manufacturing Engineer **Department**: Engineering - Manufacturing (Assembly) **Document Purpose**: this document serves as guidance to establish the professional classification in the manufacturing engineering area, defining specific and general activities that require revision on each position to establish the correct scope and...
-
Manufacturing Engineer Junior Temporary
hace 5 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Job Title**: Manufacturing Engineer Junior Temp **Department**: Engineering - ___________________________________ **Main Purpose of Job**: (Brief Summary) - Under the direction of the Director of Mfg Engineering or VST Manager or Designee, is responsible for the design, implementation, fixturing and methodology to support manufacturing production and...
-
Manufacturing Engineer Junior Temp
hace 5 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Job Title**: Manufacturing Engineer Intern **Department**: Engineering - ___________________________________ **Main Purpose of Job**: (Brief Summary) - Under the direction of the Director of Mfg Engineering or VST Manager or Designee, is responsible for the design, implementation, fixturing and methodology to support manufacturing production and...
-
Manufacturing Engineer Intern
hace 5 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Main Purpose of Job**: (Brief Summary) - Under the direction of the Director of Mfg Engineering or VST Manager or Designee, is responsible for the design, implementation, fixturing and methodology to support manufacturing production and efficiencies. Analyze current manufacturing methods and practices, recommend, develop and prototype new processes and...
-
Manufacturing Engineer 1
hace 5 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Job Title**: Manufacturing Engineer **Department**: Engineering - Manufacturing (Assembly) **Document Purpose**: this document serves as guidance to establish the professional classification in the manufacturing engineering area, defining specific and general activities that require revision on each position to establish the correct scope and...
-
Manufacturing Engineer Assistant
hace 5 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Job Title**: Manufacturing Engineer Assistant **Main Purpose of Job**: (Brief Summary) - The individual in this position shall work with Manufacturing, Quality, Production, Administrative and Technical personnel of the campus to gather and provide information required by Engineering as required to ensure the achievement of expected quality levels,...
-
Manufacturing Engineer Assistant
hace 5 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Job Title**: Manufacturing Engineer Assistant **Main Purpose of Job**: (Brief Summary) - The individual in this position shall work with Manufacturing, Quality, Production, Administrative and Technical personnel of the campus to gather and provide information required by Engineering as required to ensure the achievement of expected quality levels,...
-
Team Lead
hace 5 meses
Heredia, Costa Rica Infotree Global Solutions A tiempo completo**JOB DESCRIPTION**: Set priorities for the team, get results across boundaries, ensure an inclusive work environment, and manage performance. - Assesses personnel and material levels to determine production schedules. - Assigns personnel and monitors the flow of work in process through the manufacturing facility. - Higher job levels establish operating...
-
Manufacturing Engineer Junior Temporary
hace 5 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Main Purpose of Job**: (Brief Summary) - Under the direction of the Director of Mfg Engineering or VST Manager or Designee, is responsible for the design, implementation, fixturing and methodology to support manufacturing production and efficiencies. Analyze current manufacturing methods and practices, recommend, develop and prototype new processes and...
-
Quality Engineer 3
hace 5 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Main Purpose of Job**: Provide Quality Engineering support to the development and production of Class I, II and III (as applicable) Medical Devices. Represent Quality in production process efforts, quality planning, process validations, FMEA and Risk Analysis, support new product development activities, maintain and manage quality compliance and supplier...
-
Quality Engineer 3
hace 5 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Main Purpose of Job**: Provide Quality Engineering support to the development and production of Class I, II and III (as applicable) Medical Devices. Represent Quality in production process efforts, quality planning, process validations, FMEA and Risk Analysis, support new product development activities, maintain and manage quality compliance and supplier...
-
Manufacturing Engineer Ii
hace 5 meses
Heredia, Costa Rica Viant Medical A tiempo completo**Main Purpose of Job**: - Under the direction of the Director of Manufacturing Engineering, Engineering Manager (Product Launch or Sustaining), Value Stream Manager (VST) or Designee, is responsible for: - Providing engineering support to all required manufacturing/engineering areas in order to improve processes and provide immediate solutions to any...