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Senior Manufacturing Engineer - Medical Devices

10 years

0 Lacs

hyderabad telangana india

Posted:3 weeks ago| Platform: Linkedin logo

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Skills Required

manufacturing support development compliance design optimization drive test analyze resolve efficiency effectiveness installation lean sigma leadership audits documentation analysis engineering cad software erp mdr mentoring communication management

Work Mode

Remote

Job Type

Part Time

Job Description

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

Location:

Employment Type:


Position Summary:

Manufacturing Engineer Trainer


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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