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Validation Engineer- Medical Device

Job Description

Our client, an international Technology and consultancy company is looking for an Validation Engineer- Medical Device join their team in San Diego, CA.

Validation Engineer- Medical Device Key Duties:

  • Carry out Mechanical and Manufacturing duties, within Medical Devices

  • Partake in Method Transfer, Process Validation and performance and reports (Such as IQ/OQ/PQ)

  • Be responsible for carrying out Validation Reports for various manufacturing sites

  • Draft protocols, test reports and data analysis

  • Work on sample size determination and create these sample sizes ready for testing and verification

  • Use QC tools and statistical methods

  • Understand product BOMs and assess with reference to other information

  • Work closely with customer counterparts and understand their requirements

  • Work collaboratively with the team

  • Maintain a good knowledge of various manufacturing process

Skills and Experience:

  • Good communication and documentation skills

  • Technical proficiency in Microsoft applications

  • Knowledge on IVDR and DHF Remediation is an advantage

  • Extensive experience on using Minitab for Data analysis

  • Previous knowledge of Mechanical Design, Material billing and product life cycle stages

  • Proven track record of problem solving

  • Familiar with engineering orders and notes

This role also offers Hybrid Working Structures