Process Engineering Lead
The Process Engineer Lead (PEL) role is designed around two important elements of a "best in class" molding facility: 1) lead and/or support technical problem solving and prevention and 2) continually initiate and implement improvement ideas (either individually or by leading a small team). This is primarily done by applying knowledge of injection molding and problem-solving methodologies along with effective leadership to Process Engineers, Process Technicians, and Die Setters.
Responsibilities and activities of the PEL are designed to ensures on-time delivery of the daily schedule, optimized cycle times, and robust processing parameters that lead to predictable product quality. The Process Engineer Lead is to accomplish this through a team of direct reports as well as the application of his/her expertise. Special emphasis is placed on following GMP/procedure compliance, escalation, troubleshooting, cycle optimization and repeatability, and problem prevention.
The PEL is a leader that creates a "pro level" processing platform and team.
Specific accountabilities, authority, and responsibilities are outlined below.
Work Experience Requirements
1. 7+ years' experience in injection molding utilizing RJG scientific molding practices (Master Molder I Certification required, Master Molder II certification a plus).
2. 3+ years' experience working in GMP and ISO13485 environment with a strong emphasis on medical molding and FDA requirements.
3. Knowledge of IQ OQ PQ validation for medical molding and inputs to pFMEAs
4. 2+ years' experience in a clean room environment is preferred.
5. Proficient with Excel, Word, RJG eDART, Moldflow.
6. Proven track record of leadership, as well as a proven ability to oversee projects from start to finish.
7. Excellent written and verbal communication skills
Sthree US is acting as an Employment Business in relation to this vacancy.