Manufacturing Engineer

Job Title: Manufacturing Engineer

Location: Sacramento, CA

Duration: 12 Months

Job Summary:

We are seeking a Manufacturing Engineer with 3+ years of medical device industry experience to support manufacturing operations, process improvement, validation, and production troubleshooting in a regulated environment.

Key Responsibilities:

• Develop, optimize, and troubleshoot medical device manufacturing processes.
• Support process validation, IQ/OQ/PQ, equipment qualification, and process improvements.
• Support NPI, design transfer, engineering changes, CAPA, NCRs, and root cause investigations.
• Develop and maintain SOPs, work instructions, and manufacturing documentation.
• Partner with Quality, R&D, Operations, and Engineering teams.
• Apply Lean/Six Sigma, SPC, and continuous improvement methodologies.
• Ensure compliance with FDA regulations and ISO 13485.

Required Qualifications:

• Bachelor's degree in Engineering or related field.
• 3+ years of Manufacturing Engineering experience in the medical device industry.
• Experience with process validation, troubleshooting, and continuous improvement.
• Knowledge of FDA, ISO 13485, CAPA, NCR, and change control.
• Strong analytical, problem-solving, and technical documentation skills.