Senior Manufacturing Engineer

10 hours ago


Hyderabad, Telangana, India Tek Support Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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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