Manufacturing Engineer

Creative Solutions Services, LLC; Dexter (MI); On-site; USD 95,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a seasoned manufacturing leader to oversee technical operations in our healthcare product lines in Dexter, Michigan. This role emphasizes quality improvement, cost reduction, and regulatory compliance within a fast-paced production environment.

You will partner with cross-functional teams to drive root cause analysis, implement corrective actions, and guide continuous improvement initiatives using Lean, Six Sigma, CAPA, and PFMEA methodologies.

Qualifications

• Experience leading manufacturing teams in healthcare environments.
• Strong problem-solving and communication skills.
• Expertise with Lean, Six Sigma, CAPA and PFMEA methods.

Responsibilities

• Provide technical leadership and daily manufacturing support for multiple product families.
• Maintain and improve product quality, reduce costs, optimize processes, and ensure safety and regulatory compliance.
• Collaborate with Production, Quality, Operations, Supplier Quality and Engineering to investigate issues and drive improvements.
• Support process validation, process development, equipment improvements, and operational excellence projects.
• Demonstrate strong problem-solving, process knowledge, project management, and leadership.
• Lead initiatives using Lean Manufacturing, Six Sigma, CAPA, PFMEA and medical device quality systems.

Skills

Technical leadership

Manufacturing support

Root cause analysis

Lean manufacturing

Six Sigma

CAPA

PFMEA

Medical device quality

Project management

Technical communication

Leadership

Job description

Job Description & Skill Requirement:

• 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.