Process Engineer

Key Responsibilities

• Design, develop, and optimize manufacturing processes for medical devices.
• Lead process validation activities (IQ, OQ, PQ, and PPQ).
• Characterize, scale, and strengthen processes using DOE, SPC, Six Sigma, and Lean principles.
• Perform process FMEA, root cause analysis, and problem-solving to improve process capability (CpK ≥ 1.33).
• Coordinate process transfers from R&D to production, ensuring manufacturability and regulatory compliance.
• Collaborate with Quality and Regulatory teams to integrate process controls into the QMS and support regulatory submissions (e.g., 510(k)).
• Implement continuous improvement initiatives focused on efficiency, cost reduction, and cycle time improvement.
• Oversee qualification of equipment, tooling, and external suppliers.
• Provide technical support for New Product Introduction (NPI) activities.
• Mentor and support junior engine...