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Manufacturing Engineer II

Job Title: Manufacturing Engineer II – Medical DeviceType: W2 ContractLocation: Onsite – Plymouth, MNSummary:Looking for a Manufacturing Engineer with 1–5 years of experience to support production operations, perform investigations, and ensure compliance in a medical device environment.Key Skills:• Root Cause Analysis & Investigations • Technical Writing & Documentation • Process Validation & Computer System Validation (CSV) • Production Support & NCMR/CAPA Handling • Strong Communication & Critical Thinking.Nice to Have:• Validation & performance analysis (MSA, IQ/OQ/PQ, TMV).Responsibilities:• Provide daily support on the production floor and resolve manufacturing issues • Perform investigations, root cause analysis, and implement corrective actions (CAPA) • Handle NCMR processing and ensure product quality compliance • Develop and optimize manufacturing processes, layouts, and procedures • Support validation activities and ensure adherence to regulatory standards • Collaborate with cross-functional teams to improve efficiency and product performance • Works independently with general supervision on moderately complex projects • Contributes to process improvements and project milestones • May mentor junior team members and support cross-functional initiatives.

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