Senior Manufacturing Engineer

About the role

The Senior Manufacturing Engineer supports the production operation under the Production Superintendent, leading multiple projects, maintaining process equipment, and acting as the technical resource for the Manufacturing Manager. The role collaborates with marketing, R&D, and production teams to troubleshoot issues and drive continuous improvement.

Key responsibilities

• Own released assembly equipment and software, including documentation, calibration, preventive maintenance, and utilization.
• Ensure compliance with Quality, Environmental, Safety, ISO, and FDA regulations.
• Lead Six Sigma, Lean, Kaizen, Kanban, and Poka‑Yoke projects to reduce waste and improve safety.
• Conduct validation projects (IQ, OQ, PQ) and generate test method reports.
• Address customer complaints, perform root‑cause analysis, and develop corrective actions.
• Write and execute trials for new materials and concepts, and prepare capital expenditure requests.
• Maintain and update production floor documentation, including process SPIs and lab SPIs.
• Provide technical support to supervisors, operators, and technicians on machines, processes, and test equipment.

Required profile

• Senior‑level experience in manufacturing engineering or a related industrial field.
• Proven ability to lead cross‑functional projects and work flexible hours as needed.
• Strong understanding of ISO, FDA, and regulatory requirements.
• Excellent problem‑solving skills with a focus on safety, quality, and efficiency.

Required skills

• Six Sigma methodology
• Failure Mode and Effects Analysis (FMEA)
• Statistical Process Control (SPC) and Minitab
• Lean Manufacturing, Kaizen, Kanban, Poka‑Yoke
• IQ/OQ/PQ validation protocols
• Root‑cause analysis and corrective action planning
• Documentation and calibration management