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.
#LI-MS2
