Job Title: Manufacturing Engineer

Location: California

Duration: 12+ Months

Role Overview

We are seeking a Manufacturing Engineer to support and optimize medical device production processes. This role focuses on improving efficiency, ensuring product quality, and maintaining compliance with FDA and ISO standards.

Key Responsibilities

• Develop, implement, and improve manufacturing processes and workflows
• Support new product introduction (NPI) and design transfer to production
• Troubleshoot production issues and drive root cause analysis
• Collaborate with Quality, R&D, and Operations to ensure process performance
• Create and maintain work instructions, SOPs, and technical documentation
• Support process validation activities (IQ/OQ/PQ)
• Ensure compliance with FDA 21 CFR Part 820 and ISO 13485
• Drive continuous improvement initiatives (Lean, Six Sigma)

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related)
• 3–6 years of manufacturing engineering experience in medical devices or regulated industry
• Knowledge of GMP, process validation, and quality systems
• Strong problem-solving and analytical skills

Preferred

• Experience with cleanroom manufacturing
• Familiarity with automation and equipment qualification
• Lean or Six Sigma certification