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

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

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

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

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

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

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

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