Overview CORTLAND BIOMEDICAL – Who we are? Cortland Biomedical custom builds high-performance biomedical textile structures. The company applies over 40 years of experience in textile engineering and advanced fabric design methods to braid, knit and woven products that meet the demands of a diverse set of customers in the biomedical product space. The company also offers a full range of design, development and manufacturing services as well as a wide variety of biomedical materials. Never comfortable with the status quo, complex biomedical textile challenges are tackled with agility, credibility and curiosity. Cortland Biomedical is wholly owned by Enerpac Tool Group. Enerpac Tool Group is a premier industrial tools and services company serving a broad and diverse set of customers in more than 25 countries. The Company’s businesses are global leaders in high pressure hydraulic tools, controlled force products and solutions for precise positioning of heavy loads that help customers safely and reliably tackle some of the most challenging jobs around the world. The Company was founded in 1910 and is headquartered in Menomonee Falls, Wisconsin. Enerpac Tool Group trades on the NYSE under the symbol “EPAC”. For further information on Cortland Biomedical, visit the Company's website at https://www.cortlandbiomedical.com/ For further information on Enerpac Tool Group and its businesses, visit the Company's website at https://www.enerpactoolgroup.com/. Summary – basic function of the role Maintain biomedical textile products and processes, manufacturing methods, techniques, practices and procedures in support of ISO13485:2016 International Standard for Medical Devices and Good Manufacturing Practices. Lead and participate in continuous improvement activity for Safety, Quality, Delivery and Costs to ensure Cortland Biomedical meets/exceed customer expectations. Work Schedule: Monday – Friday Location: In-office Monday – Thursday, Friday optional work-from-home 850 Lime Hollow Rd. Cortland, NY13045 Job Duties and Responsibilities Promote safety policies and procedures during the course of normal duties. Participate in development of new or updated policies with local and corporate health and safety groups Support daily manufacturing and operations to ensure customer demands are met through a combination of problem solving and knowledge transfer to resolve process and machine issues Provide primary operations lead for the creation and management of product BOMS and routers within the company’s ERP system in support of the appropriate financial, engineering and Quality Management System (QMS) standards Propose, own and lead (when assigned) Engineering Change activities for the site Create and maintain PFMEAs, Quality Plans, Procedures, Work Instructions, Forms and other QMS documentation in support of manufacturing and operations Assist with the establishment, implementation and maintenance of Continuous Improvement methodologies including, but not limited to, 5S, Standardized Work, TPM, Pull Systems, Spare parts, etc. Responsible for the design transfer to production for the company’s internal product development process in compliance with QMS standards. This will include ensuring all product developed processes and documentation (Procedures, Work Instructions, Forms, Tooling, Material Handling, etc.) adequately support the manufacturing processes for commercial production Own and support the Corrective Action and Preventative Action (CAPA) process through individual assignments or as a team member utilizing effective problem-solving techniques and tools Support the development of specifications, identification, tracking, logistics and installation of capital investments including potential travel to supplier for site acceptance testing Write and/or execute equipment installation and operational qualifications (EIOQ), including protocol development, operator training and final reports Support NPD in the execution of performance qualifications (PQ) and other scientific protocols to support the creation of statistically based product specifications. Review and update test standards for fibers and textile structures in support of NPD development and current manufactured products Develop new technological solutions to manufacturing challenges including the use of digital tools for product documentation and traceability Expand Cortland Biomedical’s expertise in state-of-the-art engineering, manufacturing methods and materials utilization through technical journals, seminars, advance degree programs, etc.