This role involves designing, developing, and optimizing injection molding & assembly related processes to produce high-quality medical devices.

Responsibilities

Process Design & Optimization:

• Develop and optimize injection molding processes for medical devices to meet product specifications and performance requirements.

• Design, implement, and validate molding processes, including the selection of materials, molds, and machinery.

• Conduct feasibility studies for new products and processes, including cost analysis and resource planning.

Technical Support & Troubleshooting:

• Provide technical support for molding operations, including troubleshooting process issues, resolving production problems, and implementing corrective actions.

• Work closely with manufacturing teams to ensure smooth and efficient production operations.

Assembly Operations:

• Design and optimize assembly processes for medical devices, including manual and automated assembly systems.

• Develop assembly instructions, work instructions, and training materials for assembly operations.

• Monitor and improve assembly processes to enhance efficiency, reduce defects, and ensure product quality.

Quality Assurance & Compliance:

• Ensure all molding and assembly processes comply with regulatory requirements and industry standards (e.g., ISO 13485, FDA regulations).

• Develop and maintain documentation related to process validations, quality control, and product specifications.

• Perform process validations, including Design of Experiments (DOE), and statistical analysis to ensure process stability and product quality.

Project Management:

• Lead and manage engineering projects related to molding and assembly, including timeline management, resource allocation, and cross-functional team collaboration.

• Develop project plans, track progress, and report on project status to stakeholders.

Continuous Improvement:

• Identify opportunities for process improvements and lead initiatives to enhance efficiency, reduce waste, and increase overall productivity.

• Stay updated on industry trends, technologies, and best practices related to injection molding and medical device manufacturing.

Requirements

• Bachelor’s degree or Diploma in Mechanical Engineering, Manufacturing Engineering, Plastics Engineering, or a related field.

• Minimum of 3-5 years of experience in injection molding engineering, with a focus on medical molding and assembly processes.

• Proven experience in developing and optimizing injection molding processes for medical devices.

• Hands-on experience with molding machinery, molds, and assembly equipment.

• Strong knowledge of injection molding principles, materials, and technologies.

• Proficiency in process optimization, quality control, and regulatory compliance for medical devices.

• Experience with CAD software, such as SolidWorks or AutoCAD is a plus.

• Excellent problem-solving skills and the ability to troubleshoot complex issues.

• Strong project management skills with the ability to lead cross-functional teams.

• Effective communication skills, both written and verbal.