Principal Process Engineer
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This role requires a dynamic individual with strong technical acumen, exceptional interpersonal skills, and a proactive approach to project management. The Principal Process Engineer will lead process development across equipment design, process parameters, and component control.
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Key Responsibilities:
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* Develop and execute process characterization tools for medical device processes, including YAG laser welding and soldering.
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* Establish and implement validation plans that comply with regulatory standards.
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* Identify opportunities for process improvement through data analysis, experimentation, and best practices.
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* Drive alignment among cross-functional teams, including Quality Assurance and R&D.
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* Serve as a technical expert in laser welding and soldering, providing mentorship and guidance to junior engineers and manufacturing staff.
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* Maintain accurate documentation of processes, validations, and compliance efforts.
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* Achieve significant improvements in yield through effective characterization and optimization of laser welding and soldering processes.
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* Ensure successful project execution that meets critical deadlines in alignment with the company's strategic objectives.
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Requirements:
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* Bachelor's of Engineering or equivalent.
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* A minimum of 10-15 years' experience in a similar role.
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* Deep experience with Design of Experiments and statistical methods.
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* Strong technical acumen and exceptional interpersonal skills.
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* Proactive approach to project management.
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* Ability to navigate complexities and drive success.
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Technical Skills:
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* Process Engineering Expertise: In-depth knowledge of manufacturing processes, ideally in laser welding and/or soldering.
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* Statistical Analysis: Proficiency in statistical methods and tools (e.g., Design of Experiments, Six Sigma) to analyze and optimize processes.
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* Equipment Design: Knowledge of equipment/fixture design desirable.
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* Material Science Understanding: Knowledge of materials used in medical devices and how they interact with welding and soldering processes.
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