Process Engineer

Responsibilities

• Manage the design and development of new and existing automation systems to optimize manufacturing processes.
• Lead large capital projects within engineering teams and mentor other engineers.
• Support Automation Engineers in integrating automation systems with existing manufacturing hardware and equipment.
• Collaborate with Molding Engineers to specify equipment and molds for business expansion.
• Write and update process-related documentation and provide user training for manufacturing staff.
• Identify opportunities for process improvements and lead related activities.
• Collaborate with stakeholders and regulatory compliance to author required validation protocol documentation URS/FAT/SAT/IQ/OQ/PQ.
• Research, develop, and lead the implementation of advanced technologies and automation across the entire value stream.
• Interface closely with production support and maintenance departments on preventative maintenance programs.
• Generate and assist in the development of engineering plans and designs required for cost reduction, process, and equipment improvements.

Essential Skills

• Project Management experience with the ability to lead large capital projects.
• Process Engineering experience to manage design and development of automation systems.
• Proficiency in Process Failure Mode Effects Analysis (PFMEA), root causes assessments (6 M’s Fishbone), and designed engineering studies (DOE).
• Experience in medical device manufacturing and Lean Manufacturing practices.
• Strong communication skills to relay status, technical data, actions, and timelines effectively to team members and upper management.