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General Description
The Senior Project Engineer is responsible of collaborating when required on coordinating the work load for Engineering department resources; also to carry out specific assigned projects related to the development and implementation of manufacturing processes and engineering changes for medical devices, to provide support to our process and system in order to fulfill our customers expectations.
Main Responsibilities
- Identify risks in the processes, evaluate them and/or mitigate them following the safety guidelines established by the company.
- Manufacturing process revalidation due to requirement increase, change of machinery and/or replacements.
- Collaborate with Engineering Management on continuous support for all products/projects after implementation into production, maintaining continuous efforts to improve manufacturing efficiency.
- Provide training to personnel from different departments on new processes, as well as assembly and test procedures.
- To lead the processing validation, participating directly or assigning resources.
- Work as a team member with other departments and customers.
- Collaborate with Engineering Management as departmental representative before internal audit groups.
- Training of all departmental personnel in all related procedures.
- Ongoing/continual support for all products/projects after implementation into production.
- Provide support for R&D and NPI departments.
- Attending and responding to audits.
- Supervision of engineers, new product introduction and R&D projects.
Experience required.
- Knowledge in production machinery and equipment.
- Product introduction and transfers
- Processes validation IQ, OQ, PQ, TQ etc.
- Risk analysis and PFMEA
- Knowledge of ISO 13485
- Six Sigma, lean manufacturing.
- Project management
- Personnel management
- Leadership
- Communication
- Teamwork
- Bilingual Spanish/English
- Engineering Degree
