Job Title: Manufacturing Engineer

Location: Irvine, CA (Onsite)

Overview:

Seeking a Manufacturing Engineer to support medical device production and process optimization in a GMP-regulated environment. The role involves troubleshooting manufacturing issues, improving processes, and ensuring compliance with quality and regulatory standards.

Required Experience:

• 2–3 years of experience in medical device manufacturing environment
• Hands-on experience with GMP and FDA regulations
• Experience in process validation (IQ/OQ/PQ)
• Knowledge of CAPA, NCR, and root cause analysis
• Experience with documentation (SOPs, work instructions, DHR/DHF)
• Familiarity with Lean Manufacturing and continuous improvement

Key Responsibilities:

• Support day-to-day manufacturing operations and resolve production issues
• Execute and document process validation activities (IQ/OQ/PQ)
• Investigate deviations, implement CAPA, and perform root cause analysis
• Develop and update SOPs, work instructions, and manufacturing documentation
• Collaborate with quality and R&D teams to ensure product compliance
• Drive process improvements to enhance efficiency and reduce defects