Engineer II - General Project Engineering

Project Engineer

Project Engineer in Production is a combination of manufacturing technology with management science. Project Engineer in Production has the scope of engineering practices, aware of management challenges related to production.

Functional Area:

• Optimize production processes for the use of resources: materials, technology, human talent, always complying with the regulations that govern us.

• Project Engineer in Production works in a Project Team environment in regard to Capacity Increases, Scrap reduction, process improvements, poka-yoke design, Material and/or product and process changes.

• Production / Machinery transfer

• rocess validations.

• Different other projects.

Job Description:

In general, the Project Engineer is Key element in the Project Team and has the authority of suggesting changes to the product in cooperation with Denmark (BUID) and the local organization (BUD)

• Project Engineer in Production Transfer / Product changes.

• Contact person in Mexico when Denmark initiates a production transfer / product change. In regards to these changes this position has the authority of:

• Development of validation documents - Analysis of results - Preparation of validation reports - Coordination of IQ - OQ -PQ - Support maintenance documentation - Expert on the product to validate - Lead projects board MX -DK - Update Comments ( PQP's) - Generate and closing deviations - Use of good documentation practices

• Support Update PFMECA - Project Status - Teamwork

• Create and stablish a work plan for the activities to be performed.

• Coordinate the needed activities

• Development of validation documents

• Analysis of results

• Preparation of validation reports

• Coordination of IQ - OQ -PQ

• Support maintenance documentation

• Expert on the product to validate

• Lead projects board MX -DK

• Update Comments (PQP 's)

• Generate and closing deviations

• Use of good documentation practices

• Support Update PFMECA

• Project Status

• Teamwork

Responsabilities:

Maintain Denmark and the local organization informed of the activities and the

progress of the projects.

Fulfil the procedures and rules that involves the projects, as well as the economical aspect.

Validation:

• Perform validation of required processes.

• Create, develop and carry out validation activities fulfilling the requirements of approved protocols.

• Coordinate production runs, test runs and any other related activities to process validations.

• Initial validation of new process equipment, if required based on risk assessment.

• Re-validation method and frequency as defined.

• Regular follow up on re-validation plans and that re-validation is performed.

• Assure proper review / approval of validation documentation.

Product analyzing:

• The Project Engineer will be given the tasks from production or quality if the following appears:

• Ensure machines capacity to achieve daily goals.

• Failures in Process and reduction of scrap.

• To solve a new and unknown problem in the production

• Work together with quality those criteria that are not defined for the resolution of visual problems.

• Rejections in the projects inspections which cause is not known

• In anyway a threatening problem.

• Evaluation and study of movements and times for a better balance in production lines

• Design, run, test and upgrade systems or processes, such as poka-yokes, fixtures, etc.

• Create, edit and maintain necessary documentation to explain how process or

• products must be done.

• Work closely with related departments in a Self-Directed team environment to

• assess opportunities to improve the efficiency, output and manufacturing processes.

• Review and approve the technical contents of the QMS Document and their

• coherence with other QMS documents on the behalf of the Production Manager.

• A trend in claims

• The Product Engineer is then obligated to help the organization in analyzing the problem, and in this area the Product Engineer has the power to:

• Dedicate a project organization if necessary.

• To obtain all necessary information.

• To initiate corrective actions after the analyzing.

• To initiate process- or product changes after the analyzing in cooperation with Denmark.

Different projects:

• To the project engineer will be given different task such as:

• Scrap reduction projects.

• Increase of production productivity projects.

• Improvements in the different systems within the local organization (BUD)

• Search of new local purchases

• In general it is expected that this position will help in general to improve the product at any time

Requirements:

• Engineer degree in the Mechanical, Electronic or Industrial areas

• 3 to 5 years of experience in the Engineering, projects and transfers areas

• Written and spoken English INDISPENSABLE

• Experience in production transfers

• Experience in problem solving techniques

• Experience in project management knowledge

• Familiar in the used of common compares software packages

• Molding process knowledge preferred

• Experience in machinery

• Experience in project environments

• Familiar in the used SPC tools and Lean Tools

• Experience in validation and manufacturing process validation

• Knowledge in IQ, OQ, PE in medical systems

• Communication skills

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About Convatec

Pioneering trusted medical solutions to improve the lives we touch:

Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With over 10,000 colleagues, we provide products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention, treatment for hard to heal wounds, at-risk skin and ulcerated tissue to supporting debilitating conditions, improved patient outcomes and reduced care costs. Convatec's revenues in 2025 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit: http://www.convatecgroup.com.