Imagine leveraging your Engineering expertise while working for one of the leading contract manufacturers in the world. Seize this rare opportunity to be part of a healthcare and medical business unit with the support and stability of an organization that has been in business for over 100 years.
Trelleborg Healthcare and Medical is seeking a Process Engineer to join their team. You will follow good manufacturing practices (GMP) and principles to develop robust manufacturing processes. Has a primary role in the engineering of new, modified and/or existing manufacturing operations in a clean-room environment
As a valued Trelleborg team member, you will enjoy:
Analyzes new product specifications and translates these into manufacturing processes to establish production rates, achieve expected quality levels and establish reliability of finished product.
Conducts reviews of new and revised mold tooling.
Acts as mold design review input champion.
Develops and optimizes polymer conversion process parameters for new tools.
Develops decoupled molding parameters to ensure process control.
Develops process parameters for secondary operations, including ultrasonic welding, bonding, and testing.
Conducts data analysis and collaboration with Project Engineering and Quality Engineering.
Identifies Operational Qualification (OQ) process parameters and Performance Qualification (PQ) settings.
Develops and documents standard operating procedures (SOP) and product-specific operating procedures (PSOP).
Trains manufacturing personnel on SOPs and PSOPs.
Performs DOEs, and participates in the development of control plans, Process Maps, and PFMEA documentation.
Organizes internal cross-functional teams and corresponding outside vendors needed to meet project needs. Procures equipment as needed.
Uses standard problem-solving tools, e.g., 8D, 5 Whys, Fishbone.
Applies effective inter-departmental communication and escalation.
Owns tooling and process from a manufacturability standpoint from development to production release.
Partners with Quality department on investigation and corrective action for any failed First Article Inspection or OQ/PQ.
Additional Salary Information: based on experience
About Trelleborg Healthcare & Medical
Trelleborg Healthcare & Medical helps pharmaceutical and medical device companies improve patient quality of life. We do this by forming lasting partnerships with customers who seek our expertise to accelerate innovation; to ensure reliable, high-quality product supply; and to help design, prototype and manufacture life changing components and devices.