<p>Job Summary:</p><p>This role requires an accomplished Chief Operating Officer (COO) to oversee global manufacturing and engineering functions. Reporting directly to the CEO, the COO will serve as a senior leader responsible for translating strategic objectives into rigorous operational and engineering execution across all global operations.</p><p>This position demands a strategic operator who combines broad organizational perspective with strong operational and engineering expertise. The COO will be responsible for safety, quality, delivery, cost, and capacity performance, driving scalable systems, leadership development, and technical proficiency to support ongoing expansion.</p><p><b>Core Accountabilities:</b></p><ul><li>Enterprise Operations & Engineering Leadership: Ultimate responsibility for global manufacturing and engineering outcomes across ATL regions and facilities (US, UK, Costa Rica, China, and Taiwan).</li><li>Strategy Implementation: Translate corporate strategy into cohesive operational and engineering priorities, investment plans, and quantifiable results.</li><li>Global Site Oversight: Responsible for site-level performance in safety, quality, delivery, cost, and capacity; ensure accountability among site and engineering leaders through consistent standards and metrics.</li><li>Engineering Enablement: Lead worldwide engineering functions—including manufacturing engineering, NPI, and process development—to ensure robust product launches, technology transfers, and scalable production.</li><li>Operational Excellence: Champion disciplined execution by instituting standardization, lean methodologies, and a strong operating rhythm across operations and engineering.</li><li>Growth Readiness: Ensure operational and engineering preparedness for customer scale-ups, introduction of new technologies, and evolution of operational footprints.</li><li>Quality, Safety, & Compliance: Adhere to stringent standards in regulated manufacturing environments; safety and quality are fundamental priorities.</li><li>Leadership & Talent: Develop a competent global team of operations and engineering leaders, fostering accountability, career growth, and succession planning.</li></ul><p><b>Operational Management System & Tools (typical COO oversight in global medical device manufacturing):</b></p><ul><li>Establish and lead a disciplined enterprise operating system and governance cadence, including tiered daily management, SQDC performance reviews, escalation protocols, leader standard work, MBR/QBR, AOP/strategy deployment, capital governance, and PMO execution rhythms.</li><li>Ensure effective deployment and ongoing performance of the Quality Management System (QMS) and regulatory compliance infrastructure, including eQMS processes for document control, training/LMS, CAPA, nonconformance, complaints, change control, supplier quality, and audit readiness, aligned with FDA QSR and ISO 13485.</li><li>Oversee a global EHS management system to drive injury prevention, incident reporting and investigations, risk assessment, contractor safety, and jurisdictional compliance reporting.</li><li>Oversee manufacturing execution and digital quality systems (e.g., MES/eDHR/eBR, SPC, calibration, LIMS) to ensure data integrity, traceability, and audit-ready manufacturing records across sites.</li><li>Lead integrated business planning (S&OP/IBP) capabilities and supply chain controls, including demand and supply planning, master scheduling, inventory optimization, constrained capacity planning, and supplier risk monitoring to deliver service and working-capital targets.</li><li>Provide executive oversight of ERP-enabled operational controls (order-to-cash, procure-to-pay, inventory, costing), standard cost governance, productivity measurement, and internal control discipline.</li><li>Ensure robust product lifecycle and engineering system governance (PLM, ECO/ECN, configuration management) and stage-gate execution for NPI, design transfer, and technology transfer.</li><li>Oversee maintenance and reliability programs supported by CMMS/EAM, including <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">preventive/predictive</span> maintenance, spares strategy, utilities reliability, <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">validation/qualification</span> status awareness, and OEE loss elimination.</li><li>Standardize KPI definitions and performance analytics (dashboards/BI) to drive a single source of truth for safety, quality, delivery, cost, and cash; ensure structured problem solving and corrective action governance (A3/8D/5-Why).</li><li>Own operational risk management and business continuity readiness, including risk registers, supplier continuity plans, crisis management playbooks, recall readiness, and scenario planning for geopolitical and logistics disruptions.</li><li>Partner with CIO/CISO to govern IT/OT reliability and cybersecurity controls for manufacturing and regulated records, including network segmentation, access management, backup/restore testing, patch governance for OT systems, and third-party risk management.</li><li>Build scalable talent and performance management mechanisms, including role clarity (RACI), <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">capability/competency</span> frameworks, training effectiveness, succession planning, and engagement/retention routines for global operations and engineering organizations.</li></ul><p><b>Qualifications & Experience:</b></p><ul><li>Demonstrated experience as a COO, VP of Operations, or comparable executive role within a multi-site, global manufacturing company; preference given to candidates with experience in regulated industries.</li><li>Proven track record scaling operations and enhancing performance.</li><li>Expertise in manufacturing engineering, NPI, process development, and technology transfer.</li><li>Background in regulated or quality-critical manufacturing contexts.</li><li>Strong commercial and financial acumen, with experience collaborating closely with CEO, CFO, and executive teams.</li><li>Bachelor’s degree required; MBA or relevant advanced degree preferred.</li></ul><p><b>Leadership Attributes:</b></p><ul><li>Results-driven, highly accountable leader who sets clear expectations, measures outcomes, and follows through with urgency and discipline.</li><li>Strategic and enterprise-minded operator who connects strategy to execution, aligns stakeholders, and prioritizes resources to deliver safety, quality, delivery, cost, and cash objectives.</li><li>Decisive, data-informed decision maker who balances speed and rigor, escalates appropriately, and thrives in ambiguity and complex, regulated environments.</li><li>High integrity leader with an uncompromising commitment to patient safety, product quality, and compliance; models a speak-up culture and owns issues end-to-end.</li><li>Influential communicator with strong executive presence; able to simplify complex topics, drive alignment, and maintain transparent, timely stakeholder updates.</li><li>Change and transformation leader who builds commitment, removes barriers, and sustains adoption of new processes, systems, and behaviors across global sites.</li><li>People-first coach and talent developer who attracts, develops, and retains high-performing teams; invests in succession planning and leadership bench strength.</li><li>Collaborative, low-ego leader who partners effectively across functions (R&D, Quality/Regulatory, Supply Chain, Commercial, Finance, IT) and across cultures and geographies.</li><li>Customer- and patient-focused mindset with a strong bias toward continuous improvement, problem solving, and prevention (root cause, CAPA effectiveness, and right-first-time execution).</li><li>Resilient and composed under pressure; demonstrates sound judgment, constructive challenge, and steady leadership during operational disruptions and crisis situations.</li></ul><p></p>