Manufacturing Engineer II

Title: Manufacturing Engineer II

Location: Irvine, CA

Duration: 12 Months

Shift : 12 PM TO 8:30PM

100% Onsite

Summary

We are hiring a Manufacturing Engineer with 2–4 years of experience in a regulated (medical device/pharma) environment. The role involves supporting daily production, improving manufacturing processes, performing root cause analysis, and ensuring compliance with GMP/FDA standards. Candidates should have experience with process validation (IQ/OQ/PQ), statistical tools (SPC/DOE), and equipment/line support. Strong problem-solving skills and the ability to work independently in a fast-paced manufacturing setting are essential.

Responsibilities

• Support daily manufacturing operations
• Improve processes and resolve production issues
• Perform root cause analysis and implement corrective actions
• Monitor KPIs and drive continuous improvement
• Lead equipment validation and lifecycle management
• Ensure compliance with GMP, GDP, FDA, and ISO standards
• Maintain manufacturing documentation and systems

Qualifications

• Bachelor’s degree in Engineering
• 2–4 years relevant experience (medical device preferred)

Required Skills

• Strong problem-solving (DMAIC, Root Cause Analysis)
• Statistical tools (DOE, SPC, basic data analysis)
• Knowledge of GMP, FDA, and ISO regulations
• Equipment validation (IQ/OQ/PQ) and process validation
• SAP (BOMs, routers) or similar ERP systems
• Process improvement and lean manufacturing concepts
• Good communication and cross-functional collaboration
• Proficiency in MS Office (Excel, Word, PowerPoint)

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.