Lead Mechanical Engineer II

About the role

The Manufacturing Engineering, Mechanical position is responsible for sustaining and improving complex manufacturing systems for high-volume production. This role focuses on enhancing assembly efficiency, developing and refining components, tooling and equipment, and ensuring robust processes through risk assessment and validation activities.

What you'll do

• Responsible for sustaining and improving complex manufacturing systems for high-volume production
• Develop, refine, and maintain high‑volume manufacturing documentation including BOMs, workflows, assembly plans
• Design, qualify, and implement manufacturing tools, fixtures, and equipment and execute reliability, repeatability
• Perform PFMEA, validation activities (IQ/OQ/PQ), and critical testing to mitigate production risks and ensure adherence to medical device quality systems and regulatory…
• Execute root cause analysis, failure analysis, corrective actions, and change order implementation for product and process issues and generate required engineering…

What you need

• 5–9 years in mechanical & production
• FMEA
• Root cause analysis
• Mechanical engineering
• GMP
• B.Tech or B.E.

Good to have

• SolidWorks