Process Engineering Director
3 weeks ago
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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