The Director, Operations provides strategic and operational leadership for all manufacturing-related functions for the Pennsylvania based MedTech business unit, Secant Group, part of the Solesis family of companies. The Director partners with key leaders including production planning, manufacturing operations, materials management, manufacturing engineering, and site administration. This role is responsible for translating corporate strategy into actionable operating plans that drive performance, ensure operational excellence, and support business growth.

The Director develops and executes tactical initiatives to achieve key business objectives, with a focus on improving productivity, increasing yields, meeting quality and delivery commitments, and consistently achieving monthly operational metrics. The position leads continuous improvement efforts across the organization, leveraging lean manufacturing and operational excellence principles to enhance performance, efficiency, quality, customer satisfaction, and profitability.

This leader oversees the optimization of existing manufacturing processes, the development and implementation of new processes and technologies, and the timely resolution of manufacturing, product quality, and operational issues. The Director fosters a culture of accountability, collaboration, innovation, and employee engagement while ensuring compliance with all safety, regulatory, and quality requirements.

In addition, the Director serves as the Site Leader for the Perkasie and Quakertown facilities, providing overall leadership for site operations, workforce management, facility stewardship, and cross-functional coordination to ensure alignment with organizational objectives and customer expectations.

Primary Responsibilities

• Directs and oversees all Medical Component and Technical Textile manufacturing operations, including Prototyping, Yarn Preparation (Warping and Twisting), Drawing and Entering, Weaving, Knitting, Braiding, ensuring safe, efficient, and compliant operations.
• Provides leadership and direction to site Manufacturing Engineering, driving the expansion of manufacturing capabilities, implementation of new technologies, process optimization, automation initiatives, and successful introduction of new products.
• Oversees capital projects for the site and provides project management support across business functions.
• Champions the Daily Management System by leading Tier Management meetings and performance reviews, ensuring timely communication, escalation and resolution of issues related to Safety, Quality, Delivery, Cost, and People (SQDCP). Establishes accountability and drive continuous improvement throughout the organization.
• Ensures effective utilization of personnel, equipment, facilities, and materials through optimized scheduling, capacity planning, standardized work, and production controls to achieve customer requirements and business objectives.
• Develops and implements operational strategies, policies, procedures, and performance standards that support organizational goals and maximize productivity, efficiency, quality, and profitability.
• Monitors and drives performance against key operational metrics, ensuring achievement of monthly, quarterly, and annual objectives related to safety, quality, delivery, inventory, productivity, and cost reduction.
• Supports and maintains compliance with the Company's Quality Management System (QMS), ensuring adherence to ISO 13485, Good Manufacturing Practices (GMP), customer requirements, and all applicable regulatory and safety standards.
• Ensures products are manufactured, documented, released, and shipped according to established production plans and customer requirements. Utilizes operational metrics and data analytics to identify trends, address performance gaps, and drive continuous improvement initiatives.
• Collaborates with Materials Management activities and collaborate with Procurement to ensure the cost-effective and timely sourcing of raw materials. Optimize inventory management processes to support production requirements while maintaining inventory levels consistent with company objectives.
• Identify, justify, and prioritize capital equipment and facility investments required to support business growth, operational excellence, and technology advancement. Develop and manage capital expenditure plans and equipment replacement programs, collaborating with Operational Excellence and Facilities Management
• Partner with Research & Development and Engineering teams to support product development, process validation, manufacturability assessments, and successful commercialization of new products.
• Drives root cause investigations and corrective actions related to scrap, waste, yield losses, production inefficiencies, and quality concerns. Implement sustainable solutions that improve operational performance and reduce costs.
• Oversee product costing activities and collaborate with Finance to ensure accurate standard costs, cost analysis, operational forecasting, and achievement of financial objectives.
• Support customer interactions, audits, regulatory inspections, and CAPA activities by ensuring effective preparation, participation, response management, and timely resolution of findings.
• Collaborate closely with Quality Assurance to ensure compliance, product traceability, specification management, risk mitigation, and prioritization of quality activities that support manufacturing operations and customer satisfaction.
• Evaluate and improve manufacturing methods and processes utilizing expertise in product design, materials, fabrication techniques, automation, tooling, equipment capabilities, assembly methodologies, and quality systems.
• Develop annual operating budgets and manage departmental spending to achieve financial targets. Monitor and control operating expenses, capital expenditures, resource utilization, and project costs.
• Establish workforce plans that support current and future business needs. Lead talent acquisition, employee development, succession planning, performance management, and organizational capability-building initiatives.
• Serve as Site Leader for the Perkasie and Quakertown facilities, providing overall leadership for facility operations, employee engagement, safety, regulatory compliance, business continuity, and alignment with corporate objectives.

Other Duties

• Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.g., SOP's, Work Instructions) to successfully accomplish job requirements.
• Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required.
• Follows gowning procedures in designated areas.
• Follows established safety requirements and adheres to the Health Safety and Environment Management System.
• Performs other job-related responsibilities as assigned.

Qualifications

• Bachelor's degree, preferably in an engineering discipline
• A minimum of 10 years' experience, including experience in regulated manufacturing environment, preferred textile and medical device industry.
• A minimum of 4 years' experience in a management role.
• Demonstrated leadership skills and the ability to coach and mentor staff
• Must have considerable knowledge of manufacturing processes
• Knowledge of machinery, equipment, tools and textile equipment in support of yarn preparation operations, specifically as it applies to winding, twisting, direct and indirect warping
• Possess knowledge of ISO 13485, 9001 and GMP practices or possess the ability to understand and enforce the practices
• Ability to follow and make recommendation and changes to WI's and SOP's
• Ability to measure in all units of measurements and possess a high mathematical aptitude
• Considerable knowledge of ERP systems and the manufacturing workflow
• Considerable knowledge of the Microsoft Suite of products, specifically Excel, Word and Outlook
• Good presentation skills and the ability to present on a one-to-one basis and to small groups
• Ability to manage a technical project, understanding the client's needs, how the needs relate to the scope of the project and how changes will affect other systems
• Proven success in leading projects, delegating tasks, setting priorities and delivering results
• Demonstrated ability to lead and work effectively in cross functional teams and across businesses
• Strong cross-functional perspective, leadership and influencing capbilities within a matrix organization
• Comfortable working in a fast pace environment with firm deadlines.