Area Manager - DE high Voltage

Strategic Leadership & Performance 

• Own area-wide performance across key metrics (safety, quality, delivery, cost, and productivity) 

• Establish and execute goals aligned with business and operational objectives 

• Monitor KPIs and drive performance through data-driven decision-making 

• Lead capacity planning and resource alignment to meet changing demand 

Operational Oversight 

• Ensure efficient and compliant operation of production processes 

• Oversee workforce planning, labor utilization, and material flow 

• Ensure equipment readiness, capacity, and risk mitigation planning 

• Drive problem-solving for operational challenges and escalations 

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Leadership & Talent Development 

• Lead, coach, and develop supervisors and frontline employees 

• Build team capability through training, cross-training, and succession planning 

• Establish clear expectations and accountability for performance and behaviors 

• Partner with HR on workforce planning, engagement, and employee relations 

Lean Manufacturing & Continuous Improvement 

• Champion Lean Manufacturing and continuous improvement initiatives 

• Lead or sponsor Kaizen events and process improvement projects 

• Identify waste, constraints, and inefficiencies to improve flow and productivity 

• Ensure improvements are sustained and standardized 

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Cross-Functional Collaboration 

• Partner with engineering, quality, maintenance, and other business units 

• Align production execution with customer demand and business priorities 

• Support new product introduction and process changes 

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Quality, Safety & Compliance 

• Ensure adherence to safety standards, regulatory requirements, and company policies 

• Promote a culture of safety, quality, and operational discipline 

• Support audit readiness, CAPA, and compliance initiatives 

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Communication & Alignment 

• Present area performance, risks, and improvement plans to senior leadership 

• Conduct Gemba walks and maintain visibility into operations 

• Ensure alignment between strategic priorities and operational execution 

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Decision-Making Authority 

• Approves area-level staffing, resource allocation, and spending 

• Enforces policies and operational standards within the area 

• Makes strategic and operational decisions impacting area performance 

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Core Competencies 

• Leadership & people development 

• Strategic thinking with operational execution 

• Continuous improvement mindset 

• Data-driven decision making 

• Cross-functional collaboration 

• Change management 

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Minimum Qualifications 

• Bachelor’s degree in a related field or equivalent experience 

• 10+ years of operations or manufacturing leadership experience 

Area Overview 

Responsible for the DE, Mid-tier, and Glass X-ray source high voltage product lines, producing low-volume, high-mix, highly technical products including x-ray vacuum tubes, heat exchangers, and auxiliary components. 

This area supports global OEM and distribution partners in the medical device industry, operating in a complex, regulated manufacturing environment with significant technical and quality requirements. 

Area Specific Responsibilities 

• Lead production management of complex high voltage x-ray source products across a 24/7 operation 

• Own execution of daily production priorities, ensuring flow, quality, and on-time delivery 

• Partner with upstream production, supply chain, and planning teams to manage material flow and mitigate disruptions 

• Oversee WIP and inventory management within the area 

• Collaborate closely with engineering and quality teams to resolve customer issues, including warranty and avoidable mistakes (COPQ) 

• Support and lead R&D to manufacturing transitions, ensuring production readiness and scalability 

• Drive lean manufacturing execution, including Kaizen events and continuous improvement initiatives 

• Function as a project manager for operational improvements, equipment upgrades, and process changes 

• Lead strategic and tactical planning for equipment, capacity, and capital investments 

• Identify and address production constraints to improve throughput and efficiency 

• Support and ensure compliance with QMS, GMP, CAPA, and regulatory requirements for medical device manufacturing 

• Act as an operational leader for digital infrastructure initiatives (e.g., MES, SAP integration, FTZ) 

Technical/Functional Requirements 

• Experience with high-mix, low-volume manufacturing environments 

• Strong knowledge of electro-mechanical, high voltage, and/or high vacuum technologies 

• Familiarity with medical device manufacturing regulations (GMP, QMS, CAPA) 

• Experience with: 

• Lean Manufacturing and transformation initiatives 

• Root cause analysis and corrective action methodologies 

• Production system design, takt time analysis, and performance tracking 

• MES, SAP, or similar manufacturing systems 

• Proven experience managing new product introduction (NPI) and prototyping into full production 

Unique Challenges of the Role 

• Managing complex, technically advanced products with strict quality and regulatory requirements 

• Balancing production demands with ongoing R&D integration and new product introduction 

• Navigating supply chain variability, material shortages, and changing production schedules 

• Maintaining production flow amid equipment constraints and downtime risks 

• Leading across diverse teams with varying technical skill sets 

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Key Performance Objectives 

• Achieve and sustain on-time delivery (OTD), yield, and productivity targets 

• Improve production flow by identifying and addressing constraints 

• Reduce scrap, rework, and cost of poor quality (COPQ) 

• Successfully execute continuous improvement initiatives on time and within scope 

• Build team capability through training, cross-training, and skills development 

Preferred Qualifications 

• Experience with high voltage or high vacuum manufacturing processes 

• Background in medical device or regulated manufacturing environments 

• Advanced degree or Lean/Six Sigma certification