Job Description
Location: Bonita Springs, FL
Reports to: General Manager
Type: Full‑time, On‑site
Position Summary
As the in‑house manufacturing arm of Skeletal Dynamics our Strategic Manufacturing Center is a vertically integrated, ISO 13485–certified plant focused exclusively on upper‑extremity orthopedic implants. We’re now searching for a hands‑on Sr. Manufacturing Manager who will own daily execution and build the next‑stage continuous‑improvement roadmap.
You’ll manage supervisors, programmers, operators, and technicians; coach floor discipline; and partner with Quality & Engineering to meet FDA 21 CFR §820 requirements. Programming experience is a plus—you’ll collaborate closely with our Lead Programmer to drive setup reduction and future lights‑out machining.
Key Responsibilities
- Lead shop‑floor operations—pacing, job flow, tooling readiness, and on‑time completions.
- Champion continuous‑improvement (CI) and lean initiatives: build a CI roadmap covering 5S, SMED, value‑stream mapping, and cost/part reduction.
- Drive automation & digital visibility: identify lights‑out opportunities, leverage Business Central and MachineMetrics/Power BI dashboards to convert data into real‑time decisions.
- Own operational KPIs: OEE, labor efficiency, scrap/rework, setup time, and throughput dollars/hour.
- Manage and develop the manufacturing team—supervisors, programmers, operators, techs—ensuring accountability to daily production targets, safety, and quality.
- Collaborate with Quality & Engineering for fast, data‑driven root‑cause and CAPA closure.
- Control the manufacturing budget: track labor, consumables, and tooling; deliver year‑on‑year cost/part reduction.
- Coordinate resource planning & cross‑training to build a flexible, high‑skill workforce.
- Run daily tiered meetings and maintain floor‑level visual management (SQDC, Andon, KPI boards).
Qualifications
- 8+ years of manufacturing leadership in medical device, aerospace, or precision CNC machining.
- Proven success managing 20+ floor personnel in a regulated environment.
- Deep understanding of CNC workflows; programming/CAM experience or close collaboration history preferred.
- ERP fluency (Business Central ideal); strong data orientation (OEE, labor metrics, Power BI).
- Familiarity with FDA 21 CFR §820 and ISO 13485 compliance.
- Lean / Six Sigma certification (Green or Black Belt) preferred.
- Leadership traits: floor‑visible, decisive, coach‑minded, and relentless about safety & quality.
What Success Looks Like
- Daily output is predictable, efficient, and clearly communicated through visible KPIs.
- Operators, programmers, and supervisors are fully trained, cross‑functional, and self‑directed.
- Continuous‑improvement projects are prioritized and delivering tangible gains in throughput, setup reduction, and cost/part.
- Automation pilots (e.g., lights‑out machining, digital dashboards) are launched and expanding based on measurable success.
- The manufacturing floor runs with disciplined visual management and requires minimal escalation from the GM.