Role: Senior Manufacturing Engr
Location: Irvine, CA - 92614
Duration: 9 Months
About the Role:
We are looking for a highly skilled Manufacturing Engineer with strong expertise in equipment validation (IQ/OQ/PQ). This role is critical to accelerating validation timelines and requires someone who can contribute immediately with minimal onboarding.
Key Responsibilities:
• Execute Installation, Operational & Performance Qualifications (IQ/OQ/PQ)
• Interpret engineering drawings, schematics & technical documents
• Analyze production processes and improve efficiency
• Ensure compliance with quality and validation standards
• Evaluate data and generate validation reports
• Collaborate with cross-functional teams on manufacturing initiatives
Must-Have Skills:
• Hands-on experience in IQ/OQ/PQ validation
• Medical device industry experience
• Strong understanding of validation concepts
• Ability to work independently with minimal guidance
• Exposure to software validation
• Prior experience with similar large-scale medical device companies
Qualifications:
• Bachelor’s degree in Engineering
• 5–7 years of relevant experience
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