Manufacturing Process Engineer

Job Summary

We are seeking a Manufacturing Process Engineer with at least 3 years of experience in the Medical Device industry to support manufacturing operations, process optimization, and continuous improvement initiatives. The ideal candidate will be responsible for developing, validating, and improving manufacturing processes while ensuring compliance with FDA, ISO 13485, GMP, and other regulatory requirements.

Key Responsibilitie

• sDevelop, implement, and optimize manufacturing processes to improve product quality, efficiency, and cost-effectiveness
• .Support process validation activities including IQ, OQ, PQ, and process capability studies
• .Investigate manufacturing issues, identify root causes, and implement corrective and preventive actions (CAPA)
• .Collaborate with Quality, R&D, Operations, and Supply Chain teams to support new product introductions and process transfers
• .Prepare and maintain manufacturing documentation, work instructions, SOPs, and process specifications
• .Monitor manufacturing performance metrics and drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies
• .Support equipment qualification, maintenance, and troubleshooting activities
• .Ensure compliance with FDA regulations, ISO 13485 standards, GMP requirements, and internal quality procedures
• .Participate in risk assessments, FMEA activities, and change control processes
• .Support audits, inspections, and regulatory submissions as required

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Required Qualificatio

• nsBachelor's degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Manufacturing Engineering, or a related fiel
• d.Minimum 3 years of Manufacturing Process Engineering experience in the Medical Device industr
• y.Experience with process validation (IQ/OQ/PQ) and manufacturing process developmen
• t.Knowledge of FDA regulations, ISO 13485, GMP, and quality system
• s.Experience with root cause analysis, CAPA, and continuous improvement methodologie
• s.Strong problem-solving, analytical, and communication skill
• s.Ability to work effectively in a cross-functional team environmen

t.
Preferred Qualificati

• onsExperience with Lean Manufacturing, Six Sigma, or other process improvement methodologi
• es.Knowledge of risk management tools such as FM
• EA.Experience supporting new product introductions (NPI) and manufacturing transfe
• rs.Lean Six Sigma certification is a pl