Job Description Job Description JOB SUMMARY
Our Manufacturing Engineer II plays a key role in supporting new product introductions (NPI) and low-volume, high-complexity manufacturing within an FDA-regulated environment. This position provides technical and process support across Production, R&D, Quality, Service, Purchasing, and Planning while serving as a critical liaison between Engineering and Operations.
The ideal candidate will have 5+ years of engineering experience, including experience supporting new product introductions and manufacturing implementation activities. This individual will drive manufacturing readiness, process improvement, cost reduction, and continuous improvement initiatives throughout the product lifecycle while providing technical leadership across cross-functional teams.
ESSENTIAL DUTIES AND 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.
QUALIFICATIONSEducation
- Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Electrical Engineering, Physics, or a related technical discipline preferred.
- Equivalent combinations of technical education and engineering experience may be considered.
Required Experience and Skills
- 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.
Preferred Experience and Skills
A preferred candidate will have experience in one or more of the areas noted below. An ideal candidate will have experience leading NPI projects from prototype through production release.
Project management and cross-functional team leadership
- Schedule and resource management
- Budget management
New Product Introduction (NPI) and product implementation experience
- Prototype and verification build support
- Manufacturing readiness and production launch activities
- Process validation and protocol development
- Design for Manufacturability (DFM) and Design to Cost (DtC)
- Transfer of new products from development into production
Lean Manufacturing, Six Sigma, 5S, and continuous improvement methodologies
Data analysis, reporting, and trend analysis
Quality Management System experience
- FDA-regulated and ISO-compliant manufacturing environments
- CAPA and complaint investigation support
- Process development and compliance activities
Experience with RF coil manufacturing or related technologies
- RF electronics
- PCB/SMT assembly processes
- Drafting and mechanical design
- ERP, MRP, or PLM systems
Production support and continuous improvement experience
- Writing work instructions and assembly manuals
- Vendor and supplier support
- Training and mentoring experience
