Process Engineer

We are seeking a skilled and detail-oriented Process Engineer with 5 years of experience in the medical device industry. The candidate will be responsible for developing, optimizing, and validating manufacturing processes to ensure product quality, regulatory compliance, and operational efficiency.

Key Responsibilities:

Develop, implement, and optimize manufacturing processes for medical device production.
Ensure processes comply with regulatory standards such as FDA, ISO 13485, and GMP.
Lead process validation activities (IQ, OQ, PQ) and maintain proper documentation.
Identify process improvements to enhance efficiency, reduce waste, and improve product quality.
Collaborate with R&D, Quality, and Production teams for new product introduction (NPI).
Perform root cause analysis and implement corrective and preventive actions (CAPA).
Monitor process performance using statistical tools (SPC, Six Sigma methodologies).
Support audits (internal and external) and ensure documentation readiness.
Train production staff on new processes and continuous improvement initiatives.

Required Qualifications:

Bachelor’s degree in Mechanical, Biomedical, Industrial Engineering, or related field.
5 years of experience in process engineering within the medical device or regulated manufacturing industry.
Strong knowledge of process validation (IQ/OQ/PQ).
Familiarity with regulatory standards (FDA, ISO 13485, GMP).

Experience with Lean Manufacturing and Six Sigma tools.
Strong analytical, problem-solving, and documentation skills.
Preferred

Skills:

Six Sigma Green Belt or equivalent certification.
Experience in cleanroom manufacturing environments.
Knowledge of risk management (FMEA, PFMEA).
Exposure to automation and process digitalization tools.

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