Manufacturing Engineer

Location: Maple Grove, MN (Hybrid) Duration: 12 months contract , possible Contract to Hire Note: - Looking for candidate who can work on W2 Position Overview We are seeking a Manufacturing Engineer III / Supplier Engineer with strong operational manufacturing experience (preferred over design experience) to support a CAPA remediation project for contract-manufactured medical devices. This role involves working cross-functionally with internal teams and 10–20 external contract manufacturers to ensure alignment between design outputs, risk management, and manufacturing processes . Key Responsibilities Review, remediate, and approve supplier process risk documentation (PFMEA) Evaluate and approve process validations & inspection validations against statistical requirements Support CAPA remediation activities related to supplier manufacturing processes Perform change management to address documentation and validation gaps Collaborate with: Quality Engineering (QE) Design teams External suppliers Ensure compliance with quality systems, policies, and procedures Drive closure of gaps across all contract manufacturers Required Qualifications 1–2+ years of experience in a manufacturing environment Experience with: IQ / OQ / PQ (Process Validation) Test Method Validation (TMV) Strong communication and stakeholder management skills Willingness to travel up to 15% Preferred Qualifications Experience working with suppliers / supply chain Background in medical devices Knowledge of: Statistical methods Six Sigma / problem-solving methodologies #J-18808-Ljbffr