Manufacturing Engineer II - Exempt

Join our team in Dexter, MI, a vibrant community offering a perfect blend of small-town charm and big-city amenities. We are seeking a dedicated professional to design and optimize manufacturing processes, ensuring efficiency and quality in our production lines.

Must Have

• Experience in equipment IQ
• Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
• Process Validation Lifecycle (from process characterization, operational qualification to performance qualification)
• Preferred experience in DOE (with Minitab)

Other Skills

• Computer and software validation CSV
• SOP Development
• Change control of Medical Devices

Nice to Have

• Change control of Medical Devices
• Equipment Commissioning / Qualification
• Process Validation
• Computer System Validation (CSV)
• Manufacturing, Packaging, and Laboratory Equipment
• Technical experience (Troubleshooting) or any similar experience or background
• Quality / Process Control / Assurance of Medical Devices
• Labeling Analyst

Responsibilities

Responsibilities may include the following and other duties may be assigned:

• Designs manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Designs arrangement of machines within plant facilities to ensure the most efficient and productive layout.
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapts machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensures processes and procedures are in compliance with regulations.

Education and Experience

• Baccalaureate degree in Engineering
• Minimum of 2 years relevant experience

Work Schedule

• 40 hours/week
• Onsite

Interview Timeline

Immediate

Product Line Support

Crescent/Nautilus