Principal Process Engineer- Growing medical device start-up Overview- Lead Process development across equipment design, process parameters and component control.
Develop and execute process characterization tools for medical device processes, ideally experienced in yag laser welding and soldering, to develop clear understanding of inputs on outputs.
Establish and implement validation plans that comply with regulatory standards, ensuring that 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.
Drive alignment among cross-functional teams, including Quality Assurance and R&D, to ensure all stakeholders are informed, engaged, and supportive throughout the process enhancement journey.
Foster strong relationships and maintain consistent communication with key teams to facilitate collaboration and shared goals.
Serve as a technical expert in laser welding and soldering, providing mentorship and guidance to junior engineers and manufacturing staff.
Collaborate with the Quality and R&D teams to address challenges and streamline processes, ensuring product integrity and compliance.
Maintain accurate documentation of processes, validations, and compliance efforts to meet regulatory requirements.
Achieve significant improvements in yield through effective characterization and optimization of laser welding and soldering processes.
Ensure successful project execution that meets critical deadlines in alignment with the company's strategic objectives.
Build a supportive and collaborative environment that fosters innovation and excellence across engineering, quality, and R&D teams.
This role requires a dynamic individual with strong technical acumen, exceptional interpersonal skills, and a proactive approach to project management, enabling the navigation of complexities and driving success.
Experience & Education Essential Bachelor's of Engineering or equivalent Desirable A minimum of 10-15 years' experience in a similar role Deep experience with Design of Experiments, 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 analyse 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.
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For more info see Skills: Manufacturing R&D Process Development Validation Medical Device