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Molding Manager

4 weeks ago

Penang, Malaysia Plexus Corp. Full time

A Plastic Molding Engineering Manager in the medical device industry is responsible for overseeing the design, development, and production of plastic components used in medical devices. This role requires a deep understanding of medical device regulations, quality control standards, and the specific requirements of the medical industry.

Key Responsibilities:

  • Manage a team of engineers, technicians, and other staff.
  • Recruit, hire, and train team members.
  • Foster a culture of innovation, continuous improvement, and adherence to quality standards.

Product Design and Development:

  • Collaborate with design engineers and product development teams to translate product concepts into manufacturable designs.
  • Ensure designs are optimized for mold set, part performance, and cost-effectiveness.
  • Oversee the design and development of injection molds and tooling.

Process Engineering:

  • Develop and optimize injection molding processes to achieve high-quality, high-yield production.
  • Conduct process validation and verification activities to ensure compliance with regulatory requirements.
  • Implement lean manufacturing principles and continuous improvement initiatives.

Quality Assurance:

  • Implement and maintain quality management systems, including ISO 13485.
  • Ensure compliance with regulatory requirements, such as FDA QSR and EU MDR.
  • Conduct quality inspections and tests to verify product conformance to specifications.
  • Analyze quality data to identify trends and implement corrective actions.

Regulatory Compliance:

  • Stay up-to-date with regulatory requirements and industry standards.
  • Prepare and submit regulatory documentation, such as design history files and validation protocols.
  • Collaborate with regulatory affairs teams to ensure compliance.
  • Manage relationships with suppliers of raw materials, molds, and other components.
  • Evaluate supplier performance and implement supplier quality programs.

Cost Control:

  • Monitor and control production costs, including material usage, labor, and tooling expenses.
  • 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.
Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Industries: Appliances, Electrical, and Electronics Manufacturing

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