Job Description

Role : Validation Engineer - Manufacturing Operations

Location : North Haven, CT (Onsite)

NEED SOMEONE WITH PRIOR MEDTRONIC EXPERIENCE

Soft Skills

• Strong ownership mindset with the ability to lead cross-functional teams under regulated constraints.
• Effective communicator with experience presenting technical content to leadership, quality, and regulatory teams.
• Ability to manage multiple priorities, drive structured problem-solving, and implement scalable engineering solutions.

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Key Responsibilities

• Oversee and optimize complex production processes for surgical devices, ensuring alignment with efficiency and quality standards.
• Act as the primary technical expert for electro-mechanical equipment issues, identifying root causes and implementing sustainable corrective actions to minimize downtime.
• Lead the development and execution of validation strategies, including Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) for new and existing equipment.
• Apply Lean principles to identify opportunities for waste reduction and process stability.
• Lead non-conformance (NCMR) and Corrective and Preventive Action (CAPA) investigations to uphold strict quality system requirements.
• Support the adaptation of machine or equipment design to factory and production conditions

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Required Qualifications

• Bachelor's degree in Electrical Engineering, Controls, Automation, Mechatronics, or related field.
• 10+ years of relevant manufacturing engineering experience (or 8+ years with a Master's degree).
• Mastery of medical device process validation (IQ/OQ/PQ), statistical analysis (Minitab), and high-volume manufacturing assembly.
• Proven ability to troubleshoot complex automated systems including robotics, motion control, and machine vision.
• Strong background in statistical analysis, including process capability, process control, DOE, and inspection design In-depth understanding of Production Part Approval Process (PPAP) for component qualification

Qualification:

• Bachelor's degree in Electrical Engineering, Controls, Automation, Mechatronics, or related field.

Pi-square technologies is a Michigan (USA) Headquartered Automotive Embedded Engineering Services company, Synergy Partner for major OEMs and Tier 1s and their implementation partners in Automotive Embedded Product Development, Projects, Requirements Analysis, Software Design, Software Implementation, Efficient Build, Release Process, and turnkey software V & V Services. We have more than 20+ years of industry expertise with specialization in the latest cutting-edge automotive technologies such as Infotainment, connected vehicles, Cyber security, OTA, and Advanced Safety/ Body electronics.

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