Manufacturing Engineer

We’re Hiring! – Manufacturing Engineer (Medical Device / Pharma)

Location:

Work Type:

Experience Level:

About the Role

Manufacturing Engineer

The ideal candidate will ensure stable, efficient, and compliant manufacturing operations by optimizing processes, reducing variability, and supporting new product introduction (NPI).

🔹 Key Responsibilities

• Evaluate, develop, and improve

  manufacturing processes

  for consistency, yield, and cost-effectiveness.
• Conduct

  process validation (IQ/OQ/PQ)

  and maintain validation documentation as per GMP standards.
• Support

  new product introduction (NPI)

  by assisting in process transfer from R&D to production.
• Prepare and update

  work instructions, process flow diagrams, and manufacturing SOPs

  .
• Perform

  root cause analysis

  and implement

  corrective/preventive actions (CAPA)

  for process deviations.
• Collaborate with design, quality, and maintenance teams to resolve production issues.
• Ensure compliance with

  ISO 13485, 21 CFR Part 820, and internal quality system procedures

  .
• Participate in

  equipment selection, installation, and qualification activities

  .
• Analyze process data, identify performance trends, and implement improvement projects (Lean, Six Sigma).
• Support continuous improvement initiatives through

  Kaizen, VSM, and 5S

  activities.

🎓 Qualifications

• Bachelor’s or Master’s degree in

  Mechanical, Industrial, Manufacturing, or Biomedical Engineering

  .
• –8 years of experience in

  manufacturing engineering

  within the

  medical device, pharma, or regulated production

  environment.
• Strong knowledge of

  GMP, ISO 13485, FDA 21 CFR Part 820

  , and validation protocols.
• Proficiency in

  process documentation, data analysis, and production troubleshooting

  .
• Hands-on experience with

  process validation, line balancing, and capacity planning

  .
• Working knowledge of

  CAD tools (AutoCAD/SolidWorks)

  for layout and process design.
• Good understanding of

  Lean Manufacturing and Six Sigma methodologies

  .
• Strong analytical, documentation, and cross-functional collaboration skills.