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.

Apply

Vacancy posted 1 day ago

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