Manufacturing Engineer
Intellectt INC
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.
Vacancy posted 3 days ago
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