Senior Manufacturing Engineer - Medical Devices

Job Title : Manufacturing Engineer – Medical Devices (Senior / Principal Level)(Remote)

Location : Hyderabad, IND

Employment Type : Part-time

Position Summary :

We are seeking an experienced Manufacturing Engineer Trainer with 10+ years of hands-on expertise in the medical device industry to 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 with FDA, 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, including IQ, OQ, PQ, and Test Method Validation in 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 technical documentation and ensuring compliance with ISO 13485, FDA 21 CFR Part 11 / 820, and EU MDR .
• Manage nonconformance investigations, root cause analysis, and corrective / preventive actions (CAPA) .
• Collaborate with suppliers to ensure incoming materials meet specifications and quality standards.

Qualifications :

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Skills Required

Iso 14971, Iso 13485, statistical analysis tools , Process Validation, Lean Manufacturing, Manufacturing Engineering, Six Sigma