New Product Development (NPD)

• Participate in early product development phases to ensure Design for Manufacturability (DFM) and Design for Assembly (DFA) principles are incorporated.
• Evaluate manufacturing risks associated with product design.
• Provide cost analyses, capacity assessments, and operational requirements during product development.
• Collaborate with R&D to optimize product designs that improve productivity, quality, and ergonomics.
• Define manufacturing strategies for new medical devices.

New Product Introduction (NPI)

• Lead industrialization and new product launch activities.
• Develop production ramp-up plans.
• Coordinate pilot builds, engineering builds, and validation activities.
• Define labor, equipment, tooling, and facility requirements.
• Establish robust manufacturing processes for commercial production.

Manufacturing Planning

• Design manufacturing layouts for new production lines.
• Conduct capacity analyses and production flow modeling.
• Balance production lines and workstations.
• Determine takt time, cycle time, and required production capacity.

Cost Management

• Develop manufacturing cost models.
• Identify cost reduction opportunities during the product design phase.
• Evaluate capital investments (CAPEX) and justify projects through ROI analysis.

Product Transfers

• Lead product transfers between manufacturing sites or from development to production.
• Ensure operational continuity and adherence to project schedules.
• Coordinate documentation, training, and manufacturing readiness activities.

Quality and Regulatory Compliance

• Ensure compliance with:

  • FDA 21 CFR Part 820
  • ISO 13485
  • GMP
  • ISO 14971 (Risk Management)

• Participate in process validations:

  • IQ (Installation Qualification)
  • OQ (Operational Qualification)
  • PQ (Performance Qualification)

• Support PFMEA, Control Plans, and risk management activities.

Continuous Improvement

• Apply Lean Manufacturing principles to new processes.
• Develop Standard Work for new operations.
• Lead productivity improvement initiatives during product launches.
• Implement visual management tools and operational control systems.

Data Analysis

• Analyze pilot build and pre-production data.

• Monitor launch metrics, including:

  • Yield
  • Scrap
  • Throughput
  • OEE (Overall Equipment Effectiveness)
  • Productivity

• Utilize statistical tools to support data-driven decision-making.