Validation Engineer – Support

Job Summary

We are seeking an experienced Validation Engineer to support manufacturing operations for surgical device production. The ideal candidate will bring strong expertise in process validation, equipment troubleshooting, and high-volume manufacturing within a regulated medical device environment.

Key Responsibilities

• Lead and execute equipment and process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Optimize and maintain complex manufacturing processes to ensure efficiency, reliability, and product quality.
• Serve as the technical expert for electro-mechanical systems, performing root cause analysis and implementing effective corrective actions.
• Troubleshoot and resolve issues in automated systems, including robotics, motion control, and machine vision technologies.
• Drive continuous improvement initiatives using Lean Manufacturing principles.
• Lead and support Non-Conformance (NCMR) and Corrective and Preventive Action (CAPA) investigations.
• Collaborate with cross-functional teams to adapt equipment designs for manufacturing and production environments.
• Ensure compliance with regulatory and quality system requirements in a medical device setting.

Required Qualifications

• Bachelor’s degree in Electrical Engineering, Controls Engineering, Automation, Mechatronics, or a related discipline.
• Minimum 10 years of relevant manufacturing engineering experience (or 8+ years with a Master’s degree).
• Strong expertise in medical device process validation (IQ/OQ/PQ).
• Proficiency in statistical analysis tools such as Minitab.
• Hands-on experience in high-volume manufacturing and assembly environments.
• Demonstrated ability to troubleshoot complex automated systems.
• Strong knowledge of:
• Statistical Process Control (SPC)
• Process Capability Analysis
• Design of Experiments (DOE)
• Inspection and measurement system design
• In-depth understanding of Production Part Approval Process (PPAP).

Preferred Skills

• Experience working in a regulated medical device manufacturing environment.
• Strong problem-solving and analytical skills.
• Excellent communication and cross-functional collaboration abilities.