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.