Engineering Consultant II – Manufacturing (Medical Device)

About the role

Engineering Consultant II will provide manufacturing and quality engineering support for a medical device manufacturer, collaborating with cross‑functional teams to resolve technical issues and drive continuous improvement.

Key responsibilities

• Manufacturing engineering: troubleshoot processes, optimize yields, reduce scrap, improve cycle times, and support equipment/tooling.
• Quality engineering: investigate non‑conformances, perform root‑cause analysis, support CAPA, conduct risk assessments and quality trend analysis.
• Process validation: assist with process characterization, IQ/OQ/PQ activities, develop validation protocols and reports, and maintain validated state.
• Change control: assess and implement technical changes to processes, equipment, materials, specifications and documentation.
• Continuous improvement: apply Lean, Six Sigma, statistical analysis and problem‑solving methods to enhance performance.
• Documentation: prepare and maintain engineering and quality records, including FMEAs, risk assessments, work instructions and investigation reports.
• Cross‑functional collaboration with Manufacturing, QA, R&D, Regulatory Affairs, Supply Chain and Maintenance.

Required profile

• Bachelor’s degree in Engineering.
• Minimum 4 years of relevant experience.
• Advanced computer proficiency with MS Office applications.
• Experience with statistical tools and continuous‑improvement methodologies.

Required skills

• MS Office (Word, Excel, PowerPoint, Project, Visio).
• Minitab statistical software.
• Lean and Six Sigma methodologies.
• Statistical analysis and problem‑solving techniques.
• Process validation (IQ/OQ/PQ) and change control.
• Risk assessment tools such as FMEA.