NPI Manufacturing Engineer II: Process & Launch Lead

Quality Electrodynamics (QED)

Mayfield (OH)

On-site

USD 80,000 - 110,000

Full time

5 hours ago

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Job summary

Quality Electrodynamics (QED) is seeking a Manufacturing Engineer II to support new product introductions and low-volume, high-complexity manufacturing in an FDA-regulated environment. You will serve as a liaison between Engineering and Operations, providing technical and process support across Production, R&D, Quality, Service, Purchasing, and Planning.

The ideal candidate has 5+ years of engineering experience, with hands-on NPI and manufacturing implementation, and a proven ability to drive

Qualifications

Minimum 5 years of engineering experience in a manufacturing environment.
Experience supporting New Product Introduction (NPI), Advanced Manufacturing Engineering (AME), or related manufacturing activities.
Experience implementing new products, equipment, processes, or manufacturing technologies into production.
Experience with ECOs, NCRs, manufacturing documentation, and process development.
Strong understanding of Design for Manufacturability (DFM) principles.
Excellent analytical, troubleshooting, and problem-solving skills.
Strong written and verbal communication skills.
Ability to work independently and effectively within cross-functional teams.
Ability and willingness to continuously develop manufacturing engineering practitioner skills, including manufacturing methodologies, DFM practices, process improvement techniques, and emerging manufacturing technologies.
Proficiency with Microsoft Office applications, including Word and Excel.

Responsibilities

Support production and repair operations by resolving manufacturing, process, and technical issues.
Provide ECO (Engineering Change Order) and NCR (Non-Conforming Material Report) support, including creation, review, implementation, and investigation activities.
Support New Product Introduction (NPI) activities, including prototype builds, design reviews, manufacturing readiness assessments, and documentation development.
Lead or support the implementation of new products, equipment, processes, and manufacturing technologies into production.
Partner with R&D Engineering to provide Design for Manufacturability (DFM) input and identify manufacturability risks early in product development.
Develop and maintain manufacturing documentation, including routers, work instructions, process flows, and manufacturing support materials.
Lead and support process improvement, cost reduction, and continuing engineering projects.
Support customer complaint investigations, CAPAs (Corrective and Preventive Actions), and Quality Management System activities.
Ensure compliance with FDA, ISO, and internal quality requirements.
Coordinate cross-functional activities to support project execution, manufacturing readiness, and operational excellence.
Serve as a technical resource for manufacturing processes, technologies, and continuous improvement initiatives.
Continuously expand manufacturing engineering expertise through self-directed learning, cross-functional collaboration, evaluation of new manufacturing methods and technologies, and application of lessons learned to improve NPI execution, manufacturability, and operational readiness.
Perform other duties as assigned.