Shoolin Inc is a staffing and technology solutions company specializing in tailored talent acquisition and recruitment excellence across Science, Engineering, Technology, Clinical & Life Sciences,…
Shoolin Inc is a staffing and technology solutions company specializing in tailored talent acquisition and recruitment excellence across Science, Engineering, Technology, Clinical & Life Sciences,…
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Job Title: Manufacturing Engineer
Location: Irvine, CA (Onsite)
Overview:
Seeking an experienced Manufacturing Engineer to support medical device manufacturing operations. The role will focus on process validation, regulatory compliance, and continuous improvement initiatives within a regulated environment.
Required Experience:
• 3+ years of
manufacturing engineering experience in the medical device industry
• Strong experience with
process validation (IQ/OQ/PQ)
and
statistical methods
• Working knowledge of
FDA 21 CFR Part 820
and
ISO 13485
• Experience with
Lean Manufacturing and/or Six Sigma methodologies
Key Responsibilities:
• Lead and execute IQ/OQ/PQ process validations
• Ensure compliance with FDA and ISO quality standards
• Support manufacturing process improvements and optimization
• Apply statistical tools for process analysis and control
• Drive continuous improvement initiatives using Lean/Six Sigma principles
