Project Engineer II

Role: Project Engineer II overseeing capital projects, manufacturing support, and continuous improvement initiatives within the medical device sector. Responsibilities include managing project timelines and budgets, leading process validation and monitoring, investigating manufacturing issues, and implementing corrective actions. The engineer collaborates across Production, Quality, R&D, and external suppliers to ensure compliant product transfer and process improvements. Requirements: Bachelor’s in Chemical or Mechanical Engineering with at least 3 years of engineering experience; medical device experience and Lean Six Sigma certification are advantageous. Skills include project management, root cause analysis, process validation, technical documentation, and proficiency with CAD, statistical tools, and lab equipment. High-value specifics: supporting manufacturing of medical devices, including validation protocols (IQ, OQ, PQ), process analysis (PFMEA, DOE), and working within cleanroom environments. Travel requirement: 5–10%. The role involves working in both office and controlled manufacturing settings, with an emphasis on adherence to GxP and regulatory standards.