Overview

Summary - basic function of the role

Design and develop biomedical textile products and processes, manufacturing methods, techniques, practices and procedures with a focus on process development to ensure the manufacture of medical device component products which meet and exceed customer expectations.

Work Schedule: Monday - Friday

Location: In-office Monday - Friday

850 Lime Hollow Rd.

Cortland, NY13045

Salary Range: $86,330 - $129,500

This role is not eligible for sponsorship.

Job Duties and Responsibilities

• Develop textile forming and finishing processes for new products in medical device applications.
• Support the development and documentation of detailed manufacturing processes to support new product development.
• Implement and optimize processes for manufacturing in a clean room environment.
• Create PFMEAs, EIOQs, Procedures, Work Instructions, Process Flows, Routers, and other QMS documentation in compliance with Cortland Biomedical QMS standards.
• Develop new technological solutions to manufacturing challenges including the use of digital tools for product documentation and traceability
• Write and execute engineering and validation protocols, to support process validations (IQ/OQ/PQ) and the creation of statistically derived product specifications.
• Responsible for the transfer of new product development processes to commercial production
• Support the creation, audit and review of test standards and methods for the analysis of design concepts and component assemblies.
• Support the identification, tracking, logistics and installation of capital equipment including potential travel for site acceptance testing.
• Support the design and manufacture of clean room compatible fixtures and tooling intended to aid manufacturing processes and interface with existing equipment.
• Expand Cortland Biomedical's expertise in state-of-the-art engineering, manufacturing methods and materials utilization through technical journals, seminars, advance degree programs, etc.

Skills and Competencies

• Effective working knowledge of mechanical engineering fundamentals.
• Familiar with the physical and mechanical characteristics of polymers, fibers, yarns and fabrics a plus
• Effective verbal communication skills and comfortable interacting with team members and customers at all levels
• Effective technical writing skills consistent with writing engineering reports and quality management system documentation.
• Must have demonstrated creative problem solving, troubleshooting, 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
• Ability to communicate effectively, develop relationships, adapt, be customer focused, and innovate.

Education and Experience

• BS Degree in Mechanical or Textile Engineering from an accredited university
• 2+ years of experience in an engineering function within a manufacturing environment - especially in highly regulated industries (medical, energy, aerospace, automotive, etc.).

Physical Demands

Employee may have to lift documents/work materials up to 30 pounds in weight. Employee may have to lift tools up to 50 pounds in weight. Employee will have to be able to walk/climb to a variety of primary work locations, including traveling by air/auto to remote sites. This can include occasional ascending or descending ladders, stairs, scaffolding, ramps, poles, and the like. Employee may move themselves in different positions to accomplish tasks in various environments including tight and confined spaces. Employee will need to move about to accomplish tasks or move from one worksite to another. Employee will need to operate machinery and/or power tools, motor vehicles, and heavy equipment. Employee will need to listen, understand, and speak with team members in person, telephonically, and electronically at all levels within a diverse workforce and with supported organizations. Employee will need to assess the accuracy, neatness, and thoroughness of the work assigned. Employee can work in front of a personal computer and telephone for long periods of time. Will have repetitive motions that include the wrists, hands, and/or fingers.

Work Environment

Primary work environment is temperature-controlled office setting or a controlled manufacturing space but may also be visiting different customers. Specific gowning and PPE requirements will be required when working in different areas. While in the manufacturing space or visiting customers, employee may be exposed to high/low temperatures, outdoor elements (such as precipitation and wind), high levels of noise, hazardous conditions, poor ventilation, small and/or enclosed spaces, or adverse environmental conditions.

The physical demands and 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.

Direct Reports

N/A

Key External Contacts/Clients

Outside Contractors and Suppliers

Machine Designers/Builders