Directing all manufacturing-related functions for the Pennsylvania-based MedTech business unit, Secant Group, is the core of this role. The Director provides strategic and operational leadership, partnering with key leaders in production planning, manufacturing operations, materials management, manufacturing engineering, and site administration. This position translates corporate strategy into actionable operating plans, drives performance, ensures operational excellence, and supports business growth.
Responsibilities
Direct and oversee 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
Provide 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
Oversee capital projects for the site and provide project management support across business functions
Champion 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)
Establish accountability and drive continuous improvement throughout the organization
Ensure 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
Develop and implement operational strategies, policies, procedures, and performance standards that support organizational goals and maximize productivity, efficiency, quality, and profitability
Monitor and drive performance against key operational metrics, ensuring achievement of monthly, quarterly, and annual objectives related to safety, quality, delivery, inventory, productivity, and cost reduction
Support and maintain 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
Ensure products are manufactured, documented, released, and shipped according to established production plans and customer requirements
Utilize operational metrics and data analytics to identify trends, address performance gaps, and drive continuous improvement initiatives
Collaborate with Materials Management activities and 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
Millions of jobs, with real people getting hired every day
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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
Drive 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
Adhere to GMP/QSR requirements and follow applicable QMS documentation (e.g., SOP’s, Work Instructions) to successfully accomplish job requirements
Follow Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required
Follow gowning procedures in designated areas
Follow established safety requirements and adhere to the Health Safety and Environment Management System
Perform other job-related responsibilities as assigned
Requirements
Bachelor’s degree, preferably in an engineering discipline
A minimum of 10 years’ experience, including experience in a 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
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
Knowledge of ISO 13485, 9001 and GMP practices or ability to understand and enforce the practices
Ability to follow and make recommendations 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 capabilities within a matrix organization
Comfortable working in a fast-paced environment with firm deadlines
About the Company
Solesis is a family of companies, including Secant Group, a Pennsylvania-based MedTech business unit. The Director also serves as the Site Leader for the Perkasie and Quakertown facilities.