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.
- 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.
- <10% domestic and international travel in support of customers, engineering projects, site acceptance tests and training
Required Capabilities (describe scope of knowledge and ability of the position):
- BS Degree in Mechanical, Industrial, Biomedical or Textile Engineering or Technology from an accredited university
- 5+ years’ experience in an engineering function within a ISO13485 manufacturing environment (or similarly regulated)
- Effective verbal and written communication skills and comfortable interacting with team members and customers at all levels.
- Must have demonstrated creative problem solving and effective engineering decision making skills
- Ability to work well independently and as a team member
- Self-starter able to work under minimal supervision
- Capable of generating and delivering presentations to management, peers and labor force
- Proficiency of computer software including design software such as AutoCAD or SolidWorks a plus
- Familiar with the physical and mechanical characteristics of polymers, fibers, yarns and fabrics a plus
- Experience with Enterprise Resource Platforms (ERP) a plus