USA
Asia
​Mexico
For reshoring or nearshoring, new molds can be obtained from Asia or the USA. Additionally, existing molds can be relocated.
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Project Management & Reshoring Strategy
  • Develop and execute a reshoring plan, including timeline, budget, and risk assessment.
  • Collaborate with cross-functional teams (design, manufacturing, supply chain) to ensure a smooth transition.
  • Evaluate potential suppliers in the USA or Mexico (just across the border) for injection molding and assembly.
  • Identify and mitigate supply chain disruptions during the transition.
  • Ensure compliance with regulatory and industry-specific standards (e.g., FDA, ISO 13485, IATF 16949).
Injection Molding Process Development
  • Oversee tooling transfer, inspection, and modification for domestic production.
  • Validate the molding process using protocols and scientific molding techniques.
  • Establish process parameters to ensure consistent part quality and cycle times.
  • Work with toolmakers and molders to implement improvements in design for manufacturability (DFM).
  • Conduct mold trials and troubleshoot any issues related to part quality, shrinkage, warpage, or surface finish.
Quality Assurance & Regulatory Compliance
  • Develop and implement a Quality Management System (QMS) aligned with industry standards:
    • Consumer: ISO 9001, ASTM standards.
    • Medical: ISO 13485, FDA 21 CFR Part 820.
    • Automotive: IATF 16949, AIAG guidelines.
  • Perform FAI (First Article Inspections) and process validation (IQ, OQ, PQ).
  • Conduct Gage R&R studies and establish SPC (Statistical Process Control) methods.
  • Perform incoming and outgoing quality inspections with control plans and sampling methodologies.
  • Implement Corrective and Preventive Actions (CAPA) for defect reduction and continuous improvement.
Supplier Development & Auditing
  • Qualify and audit new domestic suppliers to ensure capabilities and compliance.
  • Establish key performance indicators (KPIs) for suppliers related to cost, quality, and delivery.
  • Provide training to suppliers on quality expectations and molding best practices.
  • Collaborate with suppliers on process improvements and cost-reduction initiatives.
Material Selection & Testing
  • Ensure proper selection of resins and additives to match application requirements.
  • Collaborate with material suppliers to source alternatives for cost savings or compliance.
Assembly Process Transfer & Optimization
  • Evaluate and transfer secondary operations (e.g., ultrasonic welding, pad printing, over-molding).
  • Design and implement lean assembly lines with a focus on error-proofing (poka-yoke).
  • Develop work instructions, SOPs, and operator training programs.
Cost Analysis & Continuous Improvement
  • Perform cost-benefit analysis to justify reshoring efforts.
  • Implement lean manufacturing and Six Sigma methodologies to reduce waste and improve efficiency.
  • Identify opportunities for automation to reduce labor costs and improve consistency.
Regulatory and Compliance Documentation
  • Ensure all regulatory submissions, risk assessments (FMEA), and validation protocols are completed.
Customer & Stakeholder Communication
  • Serve as the technical liaison between domestic operations and customers.
  • Conduct regular updates with management and customers on reshoring progress and performance metrics.
  • Address customer concerns related to quality, lead times, and design changes.
Training & Knowledge Transfer
  • Develop training programs for domestic teams on mold maintenance, quality control, and process monitoring.

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