Senior Validation Engineer

Job Title: Validation Engineer – Manufacturing Operations

Location: North Haven, CT (Onsite) on W2

Summary:

We are seeking an experienced Validation Engineer – Manufacturing Operations to support high-volume production of surgical medical devices. This role will focus on equipment validation, process optimization, and troubleshooting complex electro‑mechanical systems within a regulated manufacturing environment. The ideal candidate will bring strong technical expertise in IQ/OQ/PQ, automation systems, and statistical analysis, along with the ability to lead cross‑functional initiatives under strict quality and compliance standards.

Key Responsibilities:

• Oversee and optimize complex production processes for surgical devices, ensuring alignment with quality, compliance, and efficiency standards.
• Serve as the primary technical expert for electro‑mechanical equipment issues, performing root cause analysis and implementing sustainable corrective actions to reduce downtime.
• Lead the development and execution of validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment.
• Apply Lean manufacturing principles to improve process stability, eliminate waste, and enhance production efficiency.
• Lead Non‑Conformance (NCMR) and Corrective and Preventive Action (CAPA) investigations to ensure compliance with Quality Management System (QMS) requirements.
• Support equipment and machine design adaptations to align with production floor requirements and operational constraints.
• Utilize statistical tools (e.g., Minitab) for process capability analysis, DOE, process control, and inspection strategy development.
• Troubleshoot and optimize automated manufacturing systems including robotics, motion control, and machine vision systems.

Required Qualifications:

• Bachelor’s degree in Electrical Engineering, Controls Engineering, Automation, Mechatronics, or related engineering field.
• 10+ years of manufacturing engineering experience.
• Strong expertise in medical device process validation (IQ/OQ/PQ) within regulated manufacturing environments.
• Hands‑on experience with high‑volume automated assembly processes.
• Proficiency in statistical analysis including process capability studies, statistical process control (SPC), Design of Experiments (DOE), and inspection design.
• In‑depth knowledge of PPAP and component qualification processes.
• Proven ability to troubleshoot complex automated systems including robotics, motion control, and machine vision technologies.

Soft Skills:

• Strong ownership mindset with the ability to lead cross‑functional teams in regulated environments.
• Effective communication skills with experience presenting technical information to leadership, quality, and regulatory stakeholders.
• Ability to manage multiple priorities, drive structured problem‑solving, and implement scalable engineering solutions.