Position Summary

The Manufacturing Engineering Manager of Manufacturing Excellence, Standards & Validation is responsible for leading the development and implementation of best practices, first-of-kind (FOK) builds, pilot production processes, and facility standards. This role ensures operational readiness, compliance with regulatory and quality requirements, and successful validation of new products, processes, and facility layouts. The position plays a critical role in bridging engineering, operations, and quality to enable scalable, efficient, and compliant manufacturing.

Role Responsibilities

Best Practices & Standards

• Develop, document, and deploy manufacturing best practices across facilities
• Establish and maintain standardized processes, work instructions, and design guidelines
• Drive continuous improvement initiatives using Lean, Six Sigma, and industry benchmarks
• Ensure consistency in execution across multiple sites or programs

First-of-Kind (FOK) & Pilot Builds

• Lead planning and execution of first-of-kind and pilot builds for new products or processes
• Collaborate with engineering, supply chain, and production teams to ensure readiness
• Identify risks, gaps, and lessons learned; implement corrective actions
• Transition pilot builds into full-scale production efficiently

Facility Layout & Manufacturing Readiness

• Design and optimize facility layouts for efficiency, safety, and scalability
• Support new facility launches, expansions, and reconfigurations
• Ensure proper material flow, ergonomics, and capacity planning
• Coordinate equipment selection, installation, and commissioning

Compliance & Regulatory Oversight

• Ensure adherence to applicable regulatory, safety, and quality standards (e.g., ISO, OSHA, GMP as applicable)
• Develop and maintain compliance frameworks and audit readiness
• Support internal and external audits and implement corrective actions

Validation & Qualification

• Lead validation activities including IQ/OQ/PQ for equipment and processes
• Develop validation protocols, plans, and documentation
• Ensure traceability, repeatability, and compliance with validation standards
• Partner with quality teams to ensure robust process qualification

Cross-Functional Leadership

• Act as a liaison between engineering, operations, quality, and supply chain
• Lead cross-functional project teams for new product introductions (NPI)
• Provide technical leadership and mentorship to engineers and specialists

Qualifications

• Bachelor's degree in Engineering, Manufacturing, Industrial Engineering, or related field
• 7–10+ years of experience in manufacturing, operations, or industrial engineering
• 5+ years of experience in a management or leadership role with direct reports
• Experience with new product introduction (NPI), pilot builds, or FOK builds
• Strong background in validation, compliance, and quality systems
• Experience with facility layout and production line design

Skills & Competencies

• Strong knowledge of Lean Manufacturing and continuous improvement methodologies
• Familiarity with regulatory standards (ISO, FDA, GMP, etc., as applicable)
• Project management and cross-functional leadership skills
• Excellent problem-solving and analytical abilities
• Strong communication and stakeholder management skills

Preferred Qualifications

• Six Sigma certification (Green Belt or Black Belt)
• Experience in highly regulated industries (e.g., aerospace, medical devices, automotive, energy)
• Knowledge of digital manufacturing tools, simulation, or MES systems

Compensation: The salary pay range for this position is $139,000 - $177,000