Area Manager- DE Mechanical Assembly

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 

• Experience leading teams and driving operational performance 

Area Overview 

Leads the DE, Mid-tier, and Glass X-ray source mechanical assembly operations, responsible for delivering complex, high-reliability medical products in a low-volume, high-mix manufacturing environment. 

This area is critical to final product integration and readiness, requiring strong coordination across upstream production, engineering, and quality to ensure precision assembly, product integrity, and regulatory compliance for global customers. 

Area Specific Responsibilities 

• Own end-to-end performance of mechanical assembly operations, including safety, quality, delivery, and cost across a 24/7 production environment 

• Drive production execution to meet on-time delivery, yield, and throughput targets 

• Lead assembly operations for complex electro-mechanical products, ensuring: 

• Consistent build quality 

• Adherence to standardized work 

• Efficient product flow through assembly stages 

• Partner with planning, supply chain, and upstream production to ensure material readiness and schedule adherence while responding to real-time disruptions 

• Collaborate with engineering and quality teams to: 

• Resolve product and process issues 

• Reduce defects, warranty concerns, and COPQ 

• Improve assembly process capability 

• Lead new product introduction (NPI) efforts within assembly, ensuring smooth transition from R&D into stable production processes 

• Champion lean manufacturing principles within assembly, focusing on: 

• Line balancing and workflow optimization 

• Standard work development and sustainment 

• Reduction in cycle time, rework, and inefficiencies 

• Lead and execute continuous improvement projects, acting as project manager for process changes, tooling upgrades, and equipment investments 

• Own assembly-related capacity planning, labor strategy, and capital planning, ensuring scalability and operational readiness 

• Ensure compliance with QMS, GMP, CAPA, and regulatory requirements, with strong emphasis on documentation accuracy and process discipline 

• Drive adoption and effectiveness of digital systems (MES, SAP, electronic records) to improve traceability and operational visibility 

Technical/Functional Requirements 

• Strong background in mechanical assembly of complex electro-mechanical systems 

• Experience operating in high-mix, low-volume manufacturing environments 

• Demonstrated experience with: 

• Lean manufacturing and assembly process optimization 

• Root cause analysis and corrective action implementation 

• Standard work development and process control 

• Production performance tracking and reporting tools 

• Experience supporting R&D to production transitions, including process development and scaling 

• Working knowledge of regulated manufacturing environments (e.g., GMP, QMS) 

Unique Challenges of the Role 

• Ensuring consistent quality and output in a complex, variable assembly environment 

• Driving standardization while managing frequent product variation and engineering changes 

• Balancing throughput with precision and strict quality/regulatory requirements 

• Maintaining operational stability amid supply chain disruptions, labor variability, and equipment constraints 

• Building workforce capability in a technically demanding assembly environment 

Key Performance Objectives 

• Deliver strong on-time delivery, first-pass yield, and productivity results 

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

• Improve efficiency through line balance, standard work, and process optimization 

• Execute and sustain continuous improvement initiatives 

• Develop a flexible, skilled workforce through training and cross-training 

Preferred Qualifications 

• Experience in precision mechanical assembly or complex technical manufacturing 

• Background in medical device or regulated production environments 

• Lean / Six Sigma certification with demonstrated application in manufacturing