Senior Process Engineer – Medical Devices

1 day ago

Chennai, Tamil Nadu, India Tek Support Full time

Job Title: Senior Process Engineer – Medical Devices

Location: Chennai, IND

Employment type: Part-time

Job Summary:

We are seeking a highly experienced Process Engineer Trainer with over 10 years of expertise in the medical device industry. The ideal candidate will be responsible for developing, optimizing, and sustaining robust manufacturing processes that ensure product quality, regulatory compliance, and operational efficiency. This role requires strong technical knowledge, leadership skills, and the ability to collaborate cross-functionally to support new product introductions, continuous improvement initiatives, and large-scale manufacturing operations.

Key Responsibilities:

  • Lead the design, development, and validation of manufacturing processes for medical devices in compliance with FDA, ISO 13485, and GMP regulations.
  • Drive process improvements to enhance product quality, reduce cost, and improve efficiency using Lean and Six Sigma methodologies.
  • Support New Product Introduction (NPI) by developing scalable and validated manufacturing processes from concept through commercialization.
  • Collaborate with R&D, Quality, and Operations teams to ensure seamless technology transfer.
  • Lead root cause investigations, implement CAPAs, and ensure corrective actions are effective and sustainable.
  • Develop and maintain process documentation, including work instructions, PFMEA, process flow diagrams, and control plans.
  • Provide technical mentorship to junior engineers and manufacturing teams.
  • Manage and support equipment selection, installation, qualification (IQ/OQ/PQ), and maintenance strategies.
  • Ensure compliance with industry standards, safety regulations, and regulatory requirements across all processes.
  • Lead cross-functional projects focusing on yield improvement, scrap reduction, and cycle time optimization.

Qualifications & Experience:

  • Bachelor's or Master's degree in Mechanical, Biomedical, Industrial, Chemical, or related Engineering field.
  • 10+ years of proven process engineering experience in the medical device industry.
  • Strong knowledge of ISO 13485, FDA 21 CFR Part 11/Part 820, and GMP requirements.
  • Hands-on experience with process validation (IQ, OQ, PQ), equipment qualification, and test method validation.
  • Expertise in Lean Manufacturing, Six Sigma, DOE, and statistical analysis tools.
  • Proven track record in new product introduction, process scale-up, and technology transfer.
  • Strong problem-solving skills with experience in root cause analysis and risk management.
  • Excellent communication, leadership, and cross-functional collaboration skills.

Preferred Skills:

  • Six Sigma Green/Black Belt certification.
  • Experience with automated manufacturing systems, robotics, or advanced manufacturing technologies.
  • Knowledge of polymer processing, assembly techniques, or packaging processes for medical devices.
  • Familiarity with software tools such as Minitab, SolidWorks, or similar engineering applications.

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