Education and Experience:
Bachelor’s degree in Mechanical Engineering or related field, or equivalent combination of education, training, and experience. Typical experience: 2–5 years.
Working knowledge of mechanical design, production troubleshooting, drawing updates, BOM issue resolution, ECN execution, NCR support, DVT/VT support, FAI support, test support, and CAPA-related failure analysis. Ability to resolve routine mechanical issues with moderate independence.
Working proficiency with SolidWorks, EPDM/PDM, ERP/M1, engineering drawings, BOM structures, test documentation, Microsoft Office, and engineering documentation systems.
Quality, Compliance, and Process Knowledge:
Working knowledge of GMPs, ECNs, NCRs, CAPA support, DVT/VT, FAI, documentation control, and manufacturing-support workflows.
Problem Solving and Reasoning:
Ability to solve routine mechanical problems, investigate causes, recommend containment or corrective actions, and escalate complex issues appropriately.
Communication and Collaboration:
Ability to communicate technical findings, documentation updates, risks, and task status with engineering, production, quality, procurement, and operations teams.
Leadership and Mentoring:
May guide interns or Level I engineers on assigned day-to-day tasks.