**Company:** DynaFlex Technologies, Inc.
**Location:** Irvine, CA
**Reports to:** Director of Operations
Summary:Responsible for developing, optimizing, and supporting manufacturing processes for Class II and III medical devices, including catheter assemblies and polymer components.
Key Responsibilities:· Develop and validate manufacturing processes (extrusion, molding, assembly, etc.).
· Drive continuous improvement for yield, cost, and throughput.
· Support new product introduction (NPI) with process feasibility and scaling.
· Author work instructions, SOPs, and validation protocols (IQ/OQ/PQ).
· Provide training and daily support to production team.
Requirements:· BS in Engineering (Mechanical, Biomedical, or related).
· 2+ years experience in medical device manufacturing.
· Working knowledge of ISO 13485 and FDA 21 CFR Part 820.
· Strong problem-solving and technical writing skills.
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