Manufacturing Engineer

:

We are seeking a Manufacturing Engineer with 5+ years of experience in the Medical Device industry to support manufacturing operations, process improvements, and new product introductions in a regulated environment. The ideal candidate will have experience with process validation, continuous improvement, and cross-functional collaboration to ensure product quality and operational efficiency

• s:
  
  Support manufacturing processes and drive continuous improvement initiative
• s.Develop and maintain manufacturing procedures, work instructions, and process documentatio
• n.Lead process validation activities including IQ/OQ/P
• Q.Investigate manufacturing issues, perform root cause analysis, and implement corrective action
• s.Support new product introduction (NPI) and technology transfer activitie
• s.Collaborate with Quality, R&D, Regulatory, and Operations teams to ensure compliance with FDA and ISO requirement
• s.Analyze production data and identify opportunities for process optimization and cost reductio
• n.Participate in CAPA, NCR, and change control activitie

• ns:
  
  Bachelor's degree in Engineering or related technical discipli
• ne.5+ years of Manufacturing Engineering experience within the Medical Device indust
• ry.
  
  Experience with process validation (IQ/OQ/PQ), CAPA, and root cause analys
• is.
  
  Knowledge of FDA regulations, GMP, and ISO 13485 require men
• ts.
  
  Strong problem-solving, communication, and project management skil
• ls.
  
  Experience supporting manufacturing operations in a regulated environme

• lls:
  
  Lean Manufacturing and Six Sigma methodolog
• ies.
  
  Experience with automation, equipment qualification, and statistical analy
• sis.
  
  Knowledge of risk management tools such as F