Manufacturing Engineer II

Job Description

Job Title: Manufacturing Engineer II – Medical Device

Type: W2 Contract

Location: Onsite – Plymouth, MN

Summary:

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.