Senior Project Engineer
hace 3 semanas
At Prodensa, we are seeking a highly skilled Senior Project Engineer to join our team.
Job Summary:
The Senior Project Engineer will be responsible for collaborating with the Engineering department to coordinate workloads, manage projects, and implement manufacturing processes and engineering changes for medical devices.
Main Responsibilities:
- Identify and mitigate risks in manufacturing processes, ensuring compliance with safety guidelines.
- Revalidate manufacturing processes due to changes in requirements, machinery, or replacements.
- Collaborate with Engineering Management to provide continuous support for products and projects after implementation.
- Provide training to personnel on new processes, assembly, and test procedures.
- Lead processing validation, participating directly or assigning resources.
- Work as a team member with other departments and customers.
- Collaborate with Engineering Management as a departmental representative before internal audit groups.
- Train departmental personnel on related procedures.
- Provide ongoing support for products and projects after implementation.
- Support R&D and NPI departments.
- Attend and respond to audits.
- Supervise engineers, new product introduction, and R&D projects.
Requirements:
- Knowledge of 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.
What We Offer:
At Prodensa, we offer a dynamic work environment, opportunities for growth and development, and a competitive compensation package.
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