Senior Manufacturing Engineer - Medical Devices

Job Title: Manufacturing Engineer – Medical Devices (Senior/Principal Level)(Remote) Location:Hyderabad, IND Employment Type:Part-timePosition Summary: We are seeking an experiencedManufacturing Engineer Trainerwith10+ years of hands-on expertise in the medical device industryto support and enhance our manufacturing operations. The ideal candidate will have a proven track record in process development, validation, scale-up, and continuous improvement while ensuring compliance withFDA, ISO 13485, and GMP regulations .Key Responsibilities: Lead the design, development, and optimization of manufacturing processes for Class II/III medical devices. Drive process validation activities, includingIQ, OQ, PQ, and Test Method Validationin compliance with regulatory requirements. Collaborate with R&D, Quality, and Regulatory teams to ensure smooth transfer of products from design to full-scale manufacturing. Identify, analyze, and resolve complex manufacturing challenges to improve efficiency, cost-effectiveness, and product quality. Oversee equipment selection, installation, and qualification (IQ/OQ/PQ), ensuring robust process capability. Lead continuous improvement initiatives using Lean, Six Sigma, and other structured problem-solving methodologies. Provide technical leadership and mentorship to junior engineers and technicians. Support audits (internal, supplier, and regulatory) by preparing technicaldocumentation and ensuring compliance with ISO 13485, FDA 21 CFR Part 11/820, and EU MDR . Managenonconformance investigations, root cause analysis, and corrective/preventive actions (CAPA) . Collaborate with suppliers to ensure incoming materials meet specifications and quality standards.Qualifications: Bachelor’s degreein Mechanical, Biomedical, Manufacturing, or related Engineering field (Master’s preferred). 10+ years of progressive experiencein manufacturing engineering within the medical device industry. Strong background inprocess validation, design transfer, and GMP manufacturing operations . Proficiency inLean Manufacturing, Six Sigma(Green/Black Belt preferred). Experience with CAD software, statistical analysis tools, and ERP/MES systems. In-depth knowledge ofFDA, ISO 13485, ISO 14971, and EU MDR regulations . Demonstrated leadership in cross-functional teams and mentoring junior staff. Excellent communication, documentation, and project management skills.

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