Chief MedTech Manufacturing & Operations Leader

LightForce Orthodontics, Inc.; Wilmington, Northern (MA, KY); Hybrid; USD 230,000 - 300,000; Full time

Benefits offered by this job

Unlimited PTO (exempt)

Paid holidays (12)

Medical, dental, vision

401(k) retirement plan

Parental leave

Snack & coffee in office

Job summary

LightForce Orthodontics, Inc. is seeking an Operations leader to scale a fully digital, 3D-printed medtech manufacturing operation from early scale to a disciplined production system capable of supporting a business beyond $250M in revenue.

You will own strategy, P&L levers, throughput, yield and cost, reporting to the President and collaborating with the executive team and board. You'll build a Lean, high-performing organization, stand up a strong Manufacturing Engineering/Technical Operations

Qualifications

• 12+ years of progressive manufacturing and operations leadership in FDA-regulated medical devices.
• Proven track record scaling manufacturing through volume and complexity.
• Deep knowledge of FDA QSR, ISO 13485, process validation, design transfer, and manufacturing controls.
• Hands-on Lean, automation, and process engineering with CapEx/OpEx budgeting.

Responsibilities

• Set the Manufacturing Strategy and multi-year roadmap to turn demand into capacity and capital plans.
• Own Production Performance including throughput, yield, cycle time, on-time delivery and cost.
• Build Technical Operations and drive automation across the operation.
• Lead NPI and Design Transfer to ensure manufacturability from day one.
• Build a Lean, high-performing organization with strong frontline leadership.
• Partner on Quality, Supply Chain and Financials to ensure regulatory compliance and budget discipline.

Skills

Strategic leadership

Manufacturing leadership

FDA compliance

ISO 13485

Lean manufacturing

Automation

Budget management

Cross-functional leadership

Process validation

Design transfer

P&L management

Education

Bachelor's degree

Technical degree preferred

Job description

LightForce Orthodontics, Inc. is seeking an Operations leader to scale a fully digital, 3D-printed medtech manufacturing operation from early scale to a disciplined production system capable of supporting a business beyond $250M in revenue.

You will own strategy, P&L levers, throughput, yield and cost, reporting to the President and collaborating with the executive team and board. You'll build a Lean, high-performing organization, stand up a strong Manufacturing Engineering/Technical Operations