Director, Operations

Solesis; Quakertown (Bucks County); On-site; USD 180,000 - 250,000; Full time

Job summary

Solesis, a Pennsylvania‑based MedTech business unit Secant Group, seeks a Director of Operations to lead all manufacturing functions across Prototyping, Yarn Preparation, Weaving, Knitting and related processes. You’ll translate corporate strategy into actionable plans, driving productivity, quality, delivery, and cost targets while ensuring safety and regulatory compliance.

You will direct Manufacturing Engineering, capital projects, and daily management systems; manage budgets, workforce

Qualifications

• Bachelor’s degree, preferably in an engineering discipline.
• Minimum 10 years’ experience in regulated manufacturing, including 4+ years in a management role.
• Strong leadership and staff coaching abilities.
• Extensive knowledge of manufacturing processes and equipment.
• Knowledge of ISO 13485, 9001 and GMP practices.
• Ability to follow and update WIs and SOPs.
• Strong mathematical aptitude and ability to measure in all units.
• ERP systems and manufacturing workflow knowledge.
• Proficiency with Microsoft Office, especially Excel, Word and Outlook.
• Excellent presentation and cross‑functional collaboration abilities.
• Experience leading technical projects and delivering results.
• Ability to work in a fast-paced environment with firm deadlines.

Responsibilities

• Directs and oversees all Medical Component and Technical Textile manufacturing operations, ensuring safety, efficiency and compliance.
• Leads site Manufacturing Engineering to expand capabilities, optimize processes, automate, and introduce new products.
• Oversees capital projects and provides cross‑functional project management support.
• Champions the Daily Management System with Tier Management meetings and SQDCP accountability.
• Ensures optimal utilization of personnel, equipment, facilities and materials through scheduling and production controls.
• Develops and implements operating policies, performance standards and cost controls to maximize productivity and profitability.
• Monitors performance against safety, quality, delivery, inventory, productivity and cost objectives.
• Ensures adherence to QMS, ISO 13485, GMP, and regulatory requirements; supports audits and CAPA.
• Collaborates with Materials Management and Procurement to source materials cost‑effectively and manage inventory.
• Partner with R&D and Engineering for product development, process validation and commercialization.
• Drives root cause investigations and implements sustainable improvements to reduce waste and yield losses.
• Oversees product costing and collaborates with Finance on forecasts and financial targets.

Skills

Strategic leadership

Cross-functional collaboration

Lean manufacturing

Project management

Operational excellence

People management

Data analysis

Communication

Education

Bachelor’s degree in engineering

Tools

ERP systems

Microsoft Office (Excel/Word/Outlook)

Job description

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 drives 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 Procurement to ensure cost‑effective and timely sourcing of raw materials. Optimizes inventory management processes to support production requirements while maintaining inventory levels consistent with company objectives.
• Identifies, justifies and prioritizes capital equipment and facility investments required to support business growth, operational excellence and technology advancement. Develops and manages capital expenditure plans and equipment replacement programs, collaborating with Operational Excellence and Facilities Management.
• Partners 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. Implements sustainable solutions that improve operational performance and reduce costs.
• Oversees product costing activities and collaborates with Finance to ensure accurate standard costs, cost analysis, operational forecasting and achievement of financial objectives.
• Supports customer interactions, audits, regulatory inspections and CAPA activities by ensuring effective preparation, participation, response management and timely resolution of findings.
• Collaborates 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.
• Evaluates and improves manufacturing methods and processes utilizing expertise in product design, materials, fabrication techniques, automation, tooling, equipment capabilities, assembly methodologies and quality systems.
• Develops annual operating budgets and manages departmental spending to achieve financial targets. Monitors and controls operating expenses, capital expenditures, resource utilization and project costs.
• Establishes workforce plans that support current and future business needs. Leads talent acquisition, employee development, succession planning, performance management and organizational capability‑building initiatives.
• Serves 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., SOPs, Work Instructions) to successfully accomplish job requirements.
• Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves and 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 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.
• 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 the ability to understand and enforce the practices.
• Ability to follow and make recommendations and changes to WIs and SOPs.
• Ability to measure in all units of measurement 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‑pace environment with firm deadlines.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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