Job Responsibilities:
- Own the production schedule end-to-end — translate demand plans into weekly/monthly targets, manage work orders from material kitting through assembly, testing, packaging, and dispatch.
- Setup production, assembly line inhouse or at CM as per the demand
- Drive first-pass yield improvement through root cause analysis, corrective actions, and process tightening on the line.
- Own production SOPs, work instructions, and Device History Records per ISO 13485. Ensure full traceability from raw material lot to finished device serial.
- Lead or support investigation of production deviations, non-conformances, and field complaints traceable to manufacturing.
- Manage production technicians, operators, and QC inspectors — shift planning, skill matrices, daily stand-ups.
- Maintain production dashboards — output vs. plan, yield trends, rework rates, scrap, and WIP. Keep ERP entries accurate and current.
Qualifications/Experience/Skills
- 6-10 years in production/manufacturing operations, at least 3 in medical devices or regulated electronics.
- Hands-on with PCBA assembly, box-build, and electromechanical production. You’ve spent real time on the floor.
- Strong grasp of ISO 13485 production controls — DHRs, process validation, calibration, non-conformance handling.
- Experience working with EMS/contract manufacturers in India.
- Comfortable with BOMs, engineering drawings, test specs, ERP-based work order management, and using yield/cycle time data to drive improvements.
- Experience scaling from NPI/pilot to volume production.
- Exposure to medical/IoT device production — firmware flashing, provisioning, connectivity testing on the line.
- Lean or Six Sigma background.