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.
Shift: Monday – Friday; 8 – 4:30 pm or 8:30 – 5:00 pm; flexible
Job Duties and Responsibilities
- Promote safety policies and procedures during the course of normal duties.
- 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.
- Assist with 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.
- Support the Corrective Action and Preventative Action (CAPA) process through individual assignments or as a team member utilizing effective problem-solving techniques and tools
- 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.
- <10% domestic and international travel in support of customers, engineering projects, site acceptance tests and training
Skills and Competencies
- 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
- Experience with Enterprise Resource Platforms (ERP) preferred
- Demonstrated 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
- Demonstrated proficiency of design software such as AutoCAD or SolidWorks a plus
- Familiar with the physical and mechanical characteristics of polymers, fibers, yarns, and fabrics a plus
Education and Experience
- BS Degree in Mechanical, Industrial, Biomedical or Textile Engineering or Technology from an accredited university
- 3+ year experience in an engineering function within a ISO13485 manufacturing environment (or similarly regulated)
- Ability to lift parts/work materials up to 50 pounds in weight.
- Able to accomplish tasks in various environments, including different positions, tight spaces, and elevated locations (ladders, lifts, platforms, roof).
- Work environments range from normal inside/outside facility spaces (offices, warehouse, mechanical room, roof and exterior) to a controlled manufacturing space with specific gowning and PPE requirements.
- Occasional work in manufacturing space with exposure to heavy levels of noise with required hearing protection.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Key External Contacts/Clients
We are committed to recruiting, hiring, training, and promoting qualified people of all backgrounds, and make all employment decisions without regard to any protected status. We will ensure your application is fairly considered and if hired, you will have an equitable opportunity to give your best at work, not because we’re required to, but because it’s the right thing to do. Cortland will provide reasonable accommodations within the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, reach out to our Talent Acquisition Team for additional information.
If you’re looking for a unique, exciting career with variety and potential for growth, Cortland offers challenges & extraordinary rewards for people on a global scale
The above statements reflect the general details necessary to describe the principle functions of the job described and shall not be construed as a detailed description of all the work requirements that may be inherent in the job.