Process Engineering Director

3 weeks ago


Lafayette, Indiana, United States RTI Surgical® Full time

The Process Engineering Manager will provide leadership to the Process Engineering team and process engineering projects to support operations and product quality.

Key responsibilities include:

  • Providing direction to team members about daily tasks and long-term goals related to company strategy and project completion.
  • Supporting process engineering efforts, including hiring, training, motivating, evaluating, and scheduling.
  • Collaborating to set process engineering priorities based on company needs.
  • Conducting performance appraisals and wage reviews for direct reports.
  • Managing the process of completing process engineering projects.
  • Establishing metrics to measure performance and output of process engineering work.
  • Providing input on and helping drive continuous improvement of key process engineering responsibilities, including project management, risk analysis, process validation, and process development.
  • Participating in process risk analysis meetings.
  • Ensuring direct reports are well-informed about company information, events, processes, and priorities.
  • Working with other CBI leaders to ensure proper communication channels exist between process engineering and other areas.
  • Understanding available data related to CBI manufacturing and using the information to drive conversations about project priorities.
  • Remaining current and applying the understanding of FDA-ISO 13485 and Quality System Requirements in carrying out duties.
  • Administering and ensuring compliance to the Cook Biotech and OSHA/IOSHA requirements for Hazard Communication.

Requirements include:

  • Proven ability to lead and manage projects.
  • Bachelor's degree in engineering with extensive work experience in process validation.
  • At least four years industry experience in medical device manufacturing and process validation.
  • Willingness to work with material derived from animal tissues.
  • Limited exposure to hazardous chemicals used in the manufacture of the product.

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