Principal Process Engineer
Lead process development across equipment design, process parameters, and component control to drive yield and efficiency.
Key Responsibilities:
1. Develop and execute process characterization tools for medical device processes, with expertise in laser welding and soldering.
2. Establish and implement validation plans that comply with regulatory standards, ensuring processes operate within defined specifications.
3. Identify opportunities for process improvement through data analysis, experimentation, and best practices.
4. Initiate and drive corrective actions and process enhancements based on findings from characterization and validation efforts.
5. Drive alignment among cross-functional teams, including Quality Assurance and R&D.
Requirements:
* Bachelor's of Engineering or equivalent.
* 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 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.