Note: The job is a remote job and is open to candidates in USA. Sriven Systems Inc. is seeking a Manufacturing Engineer specializing in medical devices. The role involves developing and optimizing manufacturing processes, leading process validation activities, and collaborating with various teams to ensure product quality and efficiency.

Responsibilities

• Develop, implement, and optimize manufacturing processes for medical device products
• Lead process validation activities including IQ, OQ, and PQ protocols and reports
• Support new product introductions (NPI) and transfer products from R&D to manufacturing
• Create and maintain manufacturing documentation, work instructions, SOPs, and process flow diagrams
• Perform root cause analysis and implement corrective and preventive actions (CAPA)
• Collaborate with Quality, R&D, Regulatory Affairs, Supply Chain, and Production teams
• Drive continuous improvement initiatives focused on quality, yield, throughput, and cost reduction

Skills

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Industrial Engineering, or a related field
• 3–8+ years of manufacturing engineering experience within the medical device industry
• Strong knowledge of FDA regulations, GMP, ISO 13485, and medical device quality systems
• Experience with process validation (IQ/OQ/PQ), CAPA, NCR, and change control
• Knowledge of Lean Manufacturing, Six Sigma, and continuous improvement methodologies
• Experience with statistical analysis and process capability studies
• Proficiency in CAD software and manufacturing process documentation
• Strong problem-solving, communication, and project management skills

Company Overview

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