Provide technical leadership and daily manufacturing support for multiple product families
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.
Qualification:
Experience in manufacturing engineering within medical devices or other regulated industries.
Strong knowledge of manufacturing processes, process validation, quality systems, and regulatory requirements.
Experience with root cause investigations, process improvements, and cross-functional project execution.
Lean Manufacturing and Six Sigma experience preferred