BASED IN
SHENZHEN CHINA
AND THE USA
SHENZHEN CHINA
AND THE USA
For reshoring or nearshoring, new molds can be obtained from China or the USA. Additionally, existing molds can be relocated.
Project Management & Reshoring Strategy
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).
- 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.
- 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.
- 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.
- Ensure proper selection of resins and additives to match application requirements.
- Collaborate with material suppliers to source alternatives for cost savings or compliance.
- 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.
- 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.
- Ensure all regulatory submissions, risk assessments (FMEA), and validation protocols are completed.
- 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.
- Develop training programs for domestic teams on mold maintenance, quality control, and process monitoring.