Manufacturing Process Engineering Lead

2 weeks ago


Elkton, Maryland, United States Terumo Medical Corporation Full time

Job Overview:

This managerial role is tasked with strategizing, overseeing, and executing initiatives aimed at enhancing manufacturing workflows for both existing and new product lines. The focus is on optimizing safety, quality, and productivity to yield superior products efficiently. This position entails direct supervision of team members, providing guidance and leadership to ensure operational success.

Key Responsibilities:

  • Ensure adherence to TMC Quality System standards concerning engineering and process control, including process controls, calibration, maintenance practices, and document control.
  • Lead the planning and execution of projects aimed at developing and qualifying new manufacturing processes or enhancing current ones to meet business objectives.
  • Provide engineering insights for the design, development, installation, and qualification of manufacturing equipment, including conducting feasibility studies and ensuring proper documentation.
  • Oversee the distribution of tasks among team members to align resources with business needs, ensuring an effective organizational structure and skillset mix.
  • Plan and troubleshoot improvements for production equipment.
  • Foster a work environment that upholds compliance with Terumo's policies.
  • Identify opportunities for cost reduction and conduct financial analyses for capital justification.
  • Manage work schedules, budgetary considerations, attend necessary meetings, and prepare monthly performance reports.
  • This role significantly influences product quality, company profitability, and production capacity through project implementation and process enhancements.
  • Engage in project performance meetings to contribute ideas and strategies for overall unit and company improvement.
  • Coordinate with personnel from other departments to ensure project completion, providing guidance to direct reports throughout the process.
  • Perform additional job-related duties as assigned.

Position Requirements:

Knowledge, Skills, and Abilities (KSAs):

  • Comprehensive understanding of statistical methods; DMAIC/six-sigma certification is advantageous.
  • Proven analytical and problem-solving capabilities.
  • Experience with Lean manufacturing principles is beneficial.
  • Background in experimental design and analysis for process development and optimization is essential.
  • Familiarity with GMP/FDA regulations and FDA process validations, including protocol development and execution.
  • Experience in leading cross-functional teams from concept to market launch of new medical devices.
  • Proficiency in Computer Aided Design, particularly Solidworks, is a plus.
  • Exceptional verbal and written communication skills.
  • Strong ability to convey complex engineering concepts to non-engineering personnel.
  • Thorough knowledge of laboratory testing and inspection equipment and tools.

Background Experience:

  • Bachelor's degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Polymer Science, Materials Science, or a related field; an advanced degree (MS/PhD) is preferred.
  • A minimum of 8 years of experience in a manufacturing setting, focusing on major manufacturing and automation projects.
  • At least 3 years of supervisory experience.
  • Experience in the development and validation of catheter and medical device manufacturing processes (e.g., extrusion, lamination, injection molding) is a plus.


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