Senior Manufacturing engineer ( Medical devices )

systemCanadaTechnologies

Mansfield, MA, United States contract

Posted: January 1, 2014

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Quick Summary

We are seeking a Senior Manufacturing engineer with a strong background in medical devices to join our team in Mansfield, MA, USA. The ideal candidate will have experience in medical products packaging process development, Kaizen events, and process validation and reporting. The successful candidate will be responsible for conducting Kaizen events, PFMEA development, and CAPA analysis.

Required Skills

Distribution of Medical Supplies Kaizen Events Gap Analysis PFMEAs CAPA Defect Evaluation Process Validation Process Improvement FDA_Conformity EN 13480

Job Description

System Canada resources have a broad range of skills in different technologies. The large skill-set has been made possible by a conscious focus on strengthening our skills base. Every person selected for our team brings something new, something that adds to our offerings. We learn continuously, both on the job and through formal training programs.

• Medical products packaging process development
• Conducting Kaizen events
• Kaizen gap analysis & fixing the gaps
• PFMEA development for Packaging process
• CAPA, Defects and Root cause analysis
• Conducting Process validation and reporting process validation results
• Packaging sterilization requirements and process understanding
• Process improvement in Manufacturing engg. lines of medical products
• Understanding of Medical FDA standards and ISO 13485 standards
• Good understanding of GD&T and inspection techniques

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