Senior Process Engineer II

Terumo-posted 3 months ago
$105,060 - $139,587/Yr
MD
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This position is responsible for leading strategic initiatives and cross-functional programs to optimize manufacturing operations. This role will drive innovation, efficiency, and scalability, and focus heavily on equipment design, build, and deployment to ensure robust, compliant, and cost-effective production.

  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Lead the design, build, and commissioning of custom manufacturing equipment and automation systems for medical device production.
  • Collaborate with R&D, Quality, and Operations to translate product requirements into scalable manufacturing solutions.
  • Develop and optimize process flows, equipment specifications, and validation protocols (IQ/OQ/PQ).
  • Drive continuous improvement initiatives using Lean, Six Sigma, and other methodologies to enhance throughput, yield, and reliability.
  • Manage capital projects, including vendor selection and coordination, budget control, and timeline adherence.
  • Ensure all equipment and processes comply with FDA, ISO 13485, and other applicable regulatory standards.
  • Support root cause analysis and corrective actions for process deviations and equipment failures.
  • Maintain documentation and traceability for all engineering activities, including design history files and risk assessments.
  • Utilizes the systems and processes in place to attract, develop, engage, train, and retain talented Associates; creating a work environment where Associates can realize their full potential, thus allowing the organization to meet business needs.
  • Perform other duties as assigned.
  • Requires a bachelor’s or master’s degree in Mechanical, Electrical or Industrial Engineering.
  • A minimum of eight years of experience in equipment design and process engineering, preferably in the medical device industry.
  • The annualized base salary range for this role is $105,060.00 to $139,587.00.
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