Job DescriptionJoin 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
Interview Timeline
Immediate
Product Line Support
Crescent/Nautilus
Meet Your RecruiterHitesh Mohanty