Manufacturing Engineer

Katalyst CRO; Dexter (MI); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO seeks a technical leader to provide daily manufacturing support for multiple product families in Healthcare's North Haven operations. The role emphasizes maintaining product quality, reducing costs, and optimizing processes while ensuring safety and regulatory compliance.

Collaborating with Production, Quality, Operations, Supplier Quality, and Engineering, the incumbent will drive root cause analysis, CAPA, PFMEA, and continuous improvement initiatives to deliver operational

Qualifications

• Strong problem-solving, manufacturing process knowledge, project management, technical communication, and leadership skills are required.
• Experience with Lean Manufacturing, Six Sigma, CAPA, PFMEA, and medical device quality systems is highly desirable.

Responsibilities

• Provide technical leadership and daily manufacturing support for multiple product families within Healthcare's North Haven manufacturing operations.
• Maintain and improve product quality, reduce manufacturing costs, optimize processes, and ensure safety and regulatory compliance.
• Partner with Production, Quality, Operations, Supplier Quality, and Engineering teams to investigate issues, perform root cause analysis, qualify components, implement corrective actions, and drive continuous improvement.
• Support process validation activities, manufacturing process development, equipment improvements, and operational excellence projects.

Skills

Strong problem-solving

Manufacturing process knowledge

Project management

Technical communication

Leadership

Tools

CAPA

PFMEA

Job description

• Provide technical leadership and daily manufacturing support for multiple product families within Healthcare's North Haven manufacturing operations.
• Responsible for maintaining and improving product quality, reducing manufacturing costs, optimizing manufacturing processes, and ensuring compliance with safety and regulatory requirements.
• Partner with Production, Quality, Operations, Supplier Quality, and Engineering teams to investigate manufacturing issues, perform root cause analysis, qualify components, implement corrective actions, and drive continuous improvement initiatives.
• Support process validation activities, manufacturing process development, equipment improvements, and operational excellence projects.
• Strong problem-solving, manufacturing process knowledge, project management, technical communication, and leadership skills are required.
• Experience with Lean Manufacturing, Six Sigma, CAPA, PFMEA, and medical device quality systems is highly desirable.