~30%→
Class III implantable battery line
- Problem
- A production line for implantable batteries powering pacemakers and neurostimulators, running at about 30% scrap, with one critical process taking 40 hours.
- What I did
- Led a system-level redesign inside an ISO 13485 / FDA quality system: automated manual steps, retrofitted equipment and built CTQ data tools. I led 4 engineers and a 50-person production floor while working on fingertip-scale implantable cells.
- Result
- Scrap ~30% → ~2%. Critical process 40 hr → ~20 min.
Process details confidential.
