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Molding Department Head

1 week ago

Penang, Malaysia Plexus Corp. Full time
Job Description

We are seeking a highly skilled Molding Manager to join our team at Plexus Corp.

Job Responsibilities
  • Team Leadership: Manage a team of engineers, technicians, and other staff members to ensure the successful execution of plastic component development projects.
  • Recruitment and Training: Recruit, hire, and train team members to possess the necessary skills and knowledge required for the role.
  • Innovation and Quality: Foster a culture of innovation, continuous improvement, and adherence to quality standards within the team.
Product Design and Development
  • Collaboration: Collaborate with design engineers and product development teams to translate product concepts into manufacturable designs.
  • Design Optimization: Ensure designs are optimized for mold set, part performance, and cost-effectiveness.
  • Tooling Development: Oversee the design and development of injection molds and tooling.
Process Engineering
  • Process Development: Develop and optimize injection molding processes to achieve high-quality, high-yield production.
  • Validation and Verification: Conduct process validation and verification activities to ensure compliance with regulatory requirements.
  • Lean Manufacturing: Implement lean manufacturing principles and continuous improvement initiatives.
Quality Assurance
  • Quality Management: Implement and maintain quality management systems, including ISO 13485.
  • Regulatory Compliance: Ensure compliance with regulatory requirements, such as FDA QSR and EU MDR.
  • Inspection and Testing: Conduct quality inspections and tests to verify product conformance to specifications.
  • Quality Data Analysis: Analyze quality data to identify trends and implement corrective actions.
Regulatory Compliance
  • Regulatory Knowledge: Stay up-to-date with regulatory requirements and industry standards.
  • Documentation Preparation: Prepare and submit regulatory documentation, such as design history files and validation protocols.
  • Supplier Management: Manage relationships with suppliers of raw materials, molds, and other components.
  • Safety and Quality: Evaluate supplier performance and implement supplier quality programs.
Cost Control
  • Cost Monitoring: Monitor and control production costs, including material usage, labor, and tooling expenses.
  • Cost Reduction Strategies: Identify cost-saving opportunities and implement cost-reduction strategies.

Required Qualifications:

  • Bachelor's degree in Mechanical Engineering, Plastics Engineering, or a related field.
  • 10+ years of experience in plastic injection molding, preferably in the medical device industry.
  • Strong understanding of medical device regulations (e.g., FDA QSR, EU MDR).
  • Experience with ISO 13485 and other quality management systems.
  • Proficiency in CAD software (e.g., SolidWorks, AutoCAD).
  • Knowledge of statistical process control (SPC) and lean manufacturing principles.
  • Excellent problem-solving, analytical, and communication skills.
  • Strong leadership and team management skills.