Principal Process Engineer
A dynamic and experienced individual is required to lead process development across equipment design, process parameters, and component control.
Key Responsibilities:
* Develop and execute process characterization tools for medical device processes, focusing on YAG laser welding and soldering to understand inputs and outputs.
* Establish and implement validation plans that comply with regulatory standards, ensuring processes operate effectively within defined specifications.
* Identify opportunities for process improvement through data analysis, experimentation, and best practices to enhance yield and efficiency.
* Initiate and drive corrective actions and process enhancements based on findings from characterization and validation efforts.
Requirements:
* Bachelor's of Engineering or equivalent degree.
* A minimum of 10-15 years' experience in a similar role.
* Deep experience with Design of Experiments and statistical methods.
Technical Skills:
* Process Engineering Expertise: In-depth knowledge of manufacturing processes, ideally in laser welding and/or soldering.
* Statistical Analysis: Proficiency in statistical methods and tools (e.g., Design of Experiments, Six Sigma) to analyze and optimize processes.
* Equipment Design: Knowledge of equipment/fixture design desirable.
* Material Science Understanding: Knowledge of materials used in medical devices and how they interact with welding and soldering processes.