Principal Process Engineer
The Principal Process Engineer will create manufacturing processes and programs, implement automated solutions, and managed multiple projects. This role will not have immediate management responsibilities, but will be expected to lead, coach, and mentor other engineers when applicable on a weekly basis. This role reports to the VP of Operations and will work closely with other engineers, the quality team, and materials scientists.
Responsibilities
- Lead the development of manufacturing processes for new products to applicable industry standards
- Apply technical experience and knowledge to innovate, design, and develop repeatable manufacturing processes
- Implement data collection systems and record keeping processes
- Map production processes, equipment layout, floor layout, and process flow in CAD or Solidworks
- Create project charter including its objectives, scope, stakeholders, and deliverables along with budget, timeline, and resources
- Provide mentorship and leadership to other engineers on staff
- Develop master validation plans including IQOQPQ for development projects
Desired Skills and Experience
- Bachelor's Degree in an engineering related field required, Master's Degree preferred but not required
- PhD and 8+ years of process development engineering experience within medical devices, aerospace, chemical products, or plastics OR
- Master's Degree and 15+ years of process development engineering experience within medical devices, aerospace, chemical products, or plastics
- Deep understanding of manufacturing, mechanical, continuous improvement, systems, and/or chemical engineering processes
- Ability to manage multiple high-profile projects simultaneously and bring them to completion on time and within budget
- Thorough understanding of processes and requirements related to CAPAs, Root Cause Analysis, Process Mapping, PFMEA, IQOQPQ, and data collection systems
- Thorough understanding of ISO 9001, ISO 13485, and/or AS9100 standards
- Previous leadership experience preferred (formal or informal) and the ability to train, coach, and mentor engineers, technicians, and operators
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