Senior Manufacturing Engineer

2 weeks ago

Hyderabad, Telangana, India Tek Support Full time

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:

  • Bachelor's degree in Mechanical, Biomedical, Manufacturing, or related Engineering field (Master's preferred).
  • 10+ years of progressive experience in manufacturing engineering within the medical device industry.
  • Strong background in process validation, design transfer, and GMP manufacturing operations.
  • Proficiency in Lean Manufacturing, Six Sigma (Green/Black Belt preferred).
  • Experience with CAD software, statistical analysis tools, and ERP/MES systems.
  • In-depth knowledge of FDA, 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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