Sr. Engineer Supervisor

Job Summary

The Technical Supervisor II provides technical and people leadership for the Engineering and Maintenance team in a regulated medical device manufacturing environment, focused on molding, automatic and semi-automatic production processes. This position oversees the daily performance, development, and effectiveness of manufacturing technicians, machinists and toolmakers and engineers responsible for equipment reliability, process optimization, and compliance. The role ensures that
production assets operate safely, efficiently, and in accordance with Terumo’s Quality System, Environmental Health & Safety standards, and applicable regulatory requirements.

Job Details/Responsibilities

• Lead, coach, supervise and evaluate a team of Manufacturing Technicians to ensure optimal performance, technical growth, and accountability in support of production and
  maintenance goals.
• Supervise preventive, predictive, and corrective maintenance programs for molding and semi-automatic systems, ensuring equipment reliability and minimal downtime. Manages
  daily priorities and assigning personnel to appropriate process/operations to ensure compliance with schedules and efficient workflow.
• Oversee engineering support for equipment installation, qualification (IQ/OQ/PQ), and process improvements in collaboration with Manufacturing, Quality, and Operations.
  Monitor and analyze maintenance and engineering performance metrics (e.g., MTBF, MTTR, OEE) to identify trends and implement improvement initiatives.
• Manage maintenance and engineering KPIs (uptime, meantime between failures, cost of maintenance, etc.), identifying trends and implementing data-driven improvements. Drive continuous improvement and Lean/TPM initiatives to reduce downtime, improve yields, and enhance equipment performance.
• Plan and prioritize resources, assign work orders, manage spare parts inventory, and coordinate with suppliers and contractors for equipment or system service.
• Administer budgets, spare parts inventory, and vendor performance to ensure cost-effective and timely service.
• Ensure compliance with FDA, GMP, ISO, OSHA, and Terumo’s Environmental Health & Safety policies; drive a culture of safety and continuous improvement.
• Support technical troubleshooting and root cause analysis of process or equipment issues, recommending and implementing effective corrective/preventive actions.
• Incumbent must follow all established Environmental Health & Safety and Quality System policies,
  programs, rules and practices, including but not limited to product and patient safety, the health and safety
  of all associates as well as the environment and community at large.
• Other related duties may be assigned.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Strong leadership and communication skills; proven ability to develop high-performing teams.
• Technical expertise in molding equipment, semi-automatic assembly systems, and process
  automation.
• Proficiency with mechanical, pneumatic, and electrical troubleshooting.
• Knowledge of FDA, GMP, ISO 13485, and OSHA standards.
• Bilingual (English and Spanish); able to write reports and present technical findings effectively.
• Experience with TPM, predictive maintenance, and continuous improvement methodologies (Lean/Six
  Sigma).
• Proficient in AutoCAD, SolidWorks, and PLC automation platforms (Allen-Bradley, Siemens, etc.).
• Familiar with SPC, DOE, and statistical data analysis tools.

Qualifications/ Background Experiences

• Bachelor’s degree in Engineering (Electrical, Mechanical, Software, Physics, Controls, or related engineering discipline).
•  Minimum 10 years of experience with manufacturing equipment and processes, including automation, with at least 5 years in a supervisory or administrative role.