Manufacturing Engineer

Company: Katalyst HealthCares & Life Sciences
Location: Milpitas
Posted on: May 28, 2023

Job Description:

Job Description

Responsibilities:

• 5+ years' experience in Electrical or Mechanical engineering or equivalent
• Exp in NPI/Advance Eng and On-Market product documentation
• Exp in working manufacturing floor and capture documentation details
• Change analysis/change order (ECN/ECO/CA/CO , etc) creation and track through approval process
• IQ/OQ/PQ documentation and execution
• Electrical OR mechanical Drawing edit (CAD Drawing in Solid works, Schematics in Altium/OrCAD) Solid works OR equivalent
• Support Process Validation, Equipment / Fixture Qualification and Component Qualification activities
• Process quality system documentation, Standard Operating Procedures ( "SOPs"), manufacturing instructions as well as other types of documentation releases such as DHFs.
• Component obsolescence management as needed
• Good understanding on medical standards and medical product development life cycle
• Familiarity with Pharmaceutical process is plus
• Manage design history files process by: reviewing and releasing on the Agile System Certificates, Design Reviews, BOM, Confidential Documents, Protocols, Validations,
• Verifications, Purchase Request for Parts, Test Reports, Software Documents, and Technical files

Keywords: Katalyst HealthCares & Life Sciences, Milpitas , Manufacturing Engineer, Engineering , Milpitas, California