Manufacturing Engineer - Insert Molding - #W2 - Intellectt INC

Job Title: Manufacturing Engineer - Insert Molding
Location: Minnetonka , MN
Duration: 12+Months

Job Description:
We are seeking an experienced Process Engineer / Manufacturing Engineer with a strong background in insert molding for our medical device manufacturing team in Maumelle, AR. The ideal candidate will have extensive experience in managing and optimizing insert molding processes and be able to independently lead projects. This role requires expertise in molding techniques, troubleshooting, and process improvement, with a focus on compliance with FDA and ISO 13485 standards.

Key Responsibilities:

• Lead the design, development, and optimization of insert molding processes for medical devices.
• Oversee daily manufacturing operations, ensuring efficient production and adherence to quality standards.
• Analyze current processes and identify opportunities for cost and cycle time reduction and improved process efficiency.
• Provide technical support for troubleshooting and resolving process-related issues, including defect resolution.
• Ensure compliance with FDA, ISO 13485, and other industry standards.
• Manage projects from concept through production, including timeline management and resource coordination.
• Collaborate with cross-functional teams to implement new manufacturing techniques and technologies.
• Maintain comprehensive documentation, including SOPs, validation protocols, and work instructions.

Required Skills:

• Proficiency in insert molding process development, troubleshooting, and optimization.
• Experience in medical device manufacturing with knowledge of FDA and ISO 13485 regulatory standards.
• Strong project management skills with the ability to lead and manage process improvements independently.
• Excellent problem-solving, analytical, and continuous improvement skills.
• Strong communication and collaboration skills, with the ability to work with cross-functional teams.