Process Development Engineer
2 weeks ago
Our client, a world leader in diagnostics and life sciences, is looking for a
Process Development
Engineer based out of Santa Clara, CA.
Job Duration:
Long Term Contract (Possibility Of Extension)
Responsibilities:
Provide hands-on process support including troubleshooting and improvement initiatives
Create and approve Work Instructions, Production Records, and other documentation for processes
Advise on improvements and ensure controls are demonstrated through completion of method validation, or computer system validation
Support or lead investigations for identified non-compliance observations (for example, Corrective and Preventative Actions ( CAPA s) and Non-Conformance Reports ( NCR s)
Education/Required Skills:
BS in the relevant field
5-8 years in Medical Device or In Vitro Diagnostics
Cartridge manufacturing, microfluidic devices or DNA Sequencing is preferred.
Prior Experience with process mapping, document generation, and testing in production environments is highly beneficial.
Experience in statistical analysis, DOE, and utilizing tools like Minitab for data analysis and interpretation.
Experience in raw material characterization, including visual inspection, chemical testing, and surface characterization.
Proficiency in process validation, equipment validation, and ensuring compliance with relevant standards and regulations.
Company Benefits:
Medical, Dental, Vision, Paid Sick leave, 401K
Please apply or send your resume to
/
Requirements
Process development, method validation, medical devices, IVD
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