Manufacturing Process Engineer
Summary:
We are seeking a skilled Manufacturing Process Engineer to lead and support a variety of material and process change projects in a regulated MedTech environment. This role focuses on optimizing manufacturing processes, ensuring compliance, and delivering high-impact improvements through structured problem-solving and cross-functional collaboration. You’ll work independently on complex issues, contribute to project leadership, and guide stakeholders through the full cycle of manufacturing changes—from planning to validation.
Responsibilities:
* Plan, execute, and validate process and material changes, ensuring no disruption to production lines.
* Design manufacturing processes, equipment layouts, tooling sequences, and procedures to improve efficiency, performance, and product quality.
* Adapt equipment and machinery designs to meet factory and production conditions.
* Investigate equipment performance and initiate corrective actions to resolve deficiencies.
* Develop and implement statistical process control (SPC) techniques to monitor and improve operations.
* Ensure manufacturing processes meet internal standards and external regulatory requirements.
* Guide engineering teams on design concepts and manufacturing best practices.
* Lead and manage cross-functional projects, track timelines, and ensure delivery within scope and budget.
* Communicate effectively across teams and present updates to senior leadership.
* Mentor junior engineers and provide input into continuous improvement initiatives.
Requirements:
* Bachelor’s Degree (Level 8) in Mechanical, Manufacturing, Automation Engineering or related technical field.
* Minimum 4 years of experience in manufacturing or operations, ideally in the medical device or regulated industry.
* Proven track record in process design, equipment layout, validation, and yield/OEE improvement.
* Strong proficiency in MS Project, Excel, and data analysis tools; experience with Lean and Six Sigma (Green/Black Belt preferred).
* Solid understanding of automated manufacturing systems, material handling, and plastics processing.
* Excellent problem-solving, project management, and communication skills.
* A self-starter with a strong drive for results, capable of leading complex projects independently.
* Project Management certification (PMP, IPMA Level C) is an advantage.
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