Principal Process Development Engineer

Our client a high potential medical device start up company are currently seeking a Principal Process Engineer to join their team. Reporting to Manufacturing Director the Principal Process Development Engineer will spearhead the characterisation and validation of critical process steps in the device manufacturing process, focusing on laser welding and soldering techniques. This role is not only technical but also requires cross-functional collaboration and project management to ensure successful implementation and alignment across various departments. The Senior Process Development Engineer will play a key role in driving yield improvements and ensuring that products meet industry standards.

Role/Responsibilities:

• 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 processesoperate 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 strategic objectives.
• Build a supportive and collaborative environment that fosters innovation and excellence across engineering, quality, and R&D teams.

• Bachelor’s of Engineering or equivalent

• A minimum of 10-15 years’ experience in a similar role
• Deep experience with Design of Experiments, statistical methods

• 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.