Operations Manager -Medical Device

Job Title: Operations ManagerLocation: Torrington CTFulltime Permanent roleJob Description:We are seeking a strategic, customer-focused Operations Leader to lead and optimize our manufacturing operations. This role is responsible for end-to-end plant execution, including Production, Manufacturing Engineering, Quality, and Maintenance. As a key member of the Senior Leadership Team, this individual will contribute to business strategy, budgeting, and operational planning, while driving daily execution and performance. The ideal candidate brings a strong foundation in engineering and quality, along with proven experience in regulated manufacturing environments. This leader will play a critical role in New Product Introduction (NPI), validation, and transfer of business, including the launch of new products and integration of equipment and processes from sister sites. This individual is a highly collaborative and people-focused leader, capable of engaging with customers, aligning cross-functional teams, and building a strong, accountable culture. Key Responsibilities Strategic & Leadership Team ContributionServe as a key member of the Senior Leadership Team, contributing to:Business strategy and long-term planningAnnual operating plans and goal deploymentOrganizational design and capability buildingProvide leadership in budget development, cost management, and operational forecastingDemonstrate strong P&L awareness, aligning operational decisions with financial performanceOperational LeadershipLead plant operations across Safety, Quality, Delivery, Cost, and People (SQDCP)Drive execution through structured daily management systems and KPIsBuild a culture of accountability, collaboration, and continuous improvementEnsure alignment between operational performance and customer expectationsCustomer Engagement & Cross-Functional CollaborationAct as a key operations-facing leader for customers, supporting:Business reviews, technical discussions, and site visitsEscalations and issue resolutionPartner closely with Customer Service and Planning to:Align demand, capacity, and production schedulesCommunicate risks and ensure delivery commitmentsCollaborate with Program Managers, Engineering, and Quality to ensure seamless executionProduction & Manufacturing ExecutionLead production through Production Managers and Shift SupervisorsEnsure delivery of production targets with focus on efficiency, throughput, and schedule attainmentOptimize performance in a high-volume, labor-intensive environmentDrive improvements in OEE, capacity, and operational flow.Engineering, NPI & ValidationLead Manufacturing Engineering and provide strong technical leadership to operationsPartner with NPI teams and Program Managers to:Support product development and transfer into manufacturingEnsure Design for Manufacturability (DFM)Execute and sustain process validation (IQ/OQ/PQ)Ensure successful launch of new products and processes, meeting quality, cost, and delivery expectationsTransfer of Business & Capacity ExpansionLead and support transfer of products, processes, and equipment from sister sitesOversee installation, qualification, and ramp-up of new machines and technologiesEnsure smooth transitions with minimal disruption to customer delivery and quality performanceAlign resources, training, and process readiness to support capacity expansionQuality & Regulatory ComplianceEnsure compliance with ISO 13485 and applicable medical device regulationsPartner with Quality to:Drive effective CAPA and root cause analysisReduce defects, scrap, and customer complaintsMaintain audit readiness and successful inspectionsPromote a proactive quality culture across operationsMaintenance & Equipment ReliabilityOversee preventive and predictive maintenance programsEnsure high levels of equipment uptime and reliabilityDrive improvements in downtime reduction and asset utilizationSupport capital investment planning and executionContinuous ImprovementLead Lean and Six Sigma initiatives across the plantDrive measurable improvements in:Throughput and cycle timeCost reductionWaste eliminationEstablish a culture of structured problem-solving and operational excellence People Leadership & CultureLead, coach, and develop teams including:Production leadershipManufacturing EngineeringMaintenance leadershipBuild a people-first, high-performance culture focused on:Engagement and accountabilityLeadership development and succession planningPartner with HR to strengthen organizational capability and culture Financial & Operational PerformanceDevelop and manage plant budgets and cost performanceDrive cost improvement initiatives and operational efficiencyUtilize KPIs and data analytics to support business decision-makingAlign operational execution with financial goals and performance targets Qualifications Bachelor's degree in EngineeringAdvanced degree (MBA or MS) is a plus10+ years of leadership experience in manufacturing operationsProven experience leading multi-functional teams (Production, Engineering, Quality, Maintenance)Strong experience with:New Product Introduction (NPI)Process validation (IQ/OQ/PQ)Transfer of business and equipment between sitesExperience in medical device manufacturing strongly preferredInjection molding experience preferred Technical & Leadership SkillsStrong expertise in:Manufacturing Engineering and process developmentValidation methodologiesQuality systems and regulatory complianceDeep understanding of ISO 13485Experience with Lean Manufacturing / Six SigmaStrong financial acumen with P&L awarenessExcellent communication skills with the ability to engage customers and internal stakeholdersStrategic & Financial AcumenTechnical & Operational LeadershipNPI & Product Launch Execution