Overview

Summary - basic function of the role

Reports into the Sales & New Business Development (NBD) organization. Leads the management of the design and development of biomedical textile products, manufacturing methods, and test methods with a focus on design feasibility, customer communication, design control documentation, and project timelines, to ensure products meet and exceed customer expectations.

Work Schedule: Monday - Friday; evenings and weekends may be required

Location: In-office Monday - Friday

850 Lime Hollow Rd.

Cortland, NY13045

Salary Range: $96,500 - $144,750

Anticipated Hire Date: September 2026

This role is not eligible for sponsorship now or in the future.

Job Duties and Responsibilities

• Consult and guide customers to biomedical textile solutions by leveraging textile forming techniques such as braiding, knitting, weaving, as well as post-processing methods to create novel structures.
• Collaborate with Sales & Sales Engineering to gather voice of customer, evaluate new project opportunities, and make strategic project decisions.
• Represent Cortland Biomedical as biomedical textile design expert.
• Establish design and manufacturing feasibility of new products.
• Document engineering work in protocols and reports. Establish documentation best practices and mentor junior engineers.
• Own execution of engineering changes and CAPAs. Establish best practices and mentor junior engineers.
• Create and maintain design control documentation including traceability matrix, design and development plan, and other quality management system (QMS) documentation in compliance with Cortland Biomedical QMS standards. Provide continuous improvement ideas and solutions for design and development documentation.
• Drive the progression of development projects through the Cortland Biomedical design and development phase gate process through execution and documentation of timely cross-functional design reviews in compliance with Cortland Biomedical QMS standards. Provide continuous improvement ideas and solutions for design and development processes and systems.
• Collaborate with engineering, operations, and quality to ensure all QMS documentation is completed in a timely manner, consistent with the project timeline.
• Manage the details of development projects including resources, timelines/Gantt charts, deliverables, milestones, recurring calls, and overall engineering communication with internal and external teams.
• Support the management of the development engineering project portfolio to ensure adequate resources are available to achieve simultaneous project milestones.
• Provide informal mentoring and/or supervision to junior team members.
• Identify raw material suppliers and work toward their approval on Cortland Biomedical's approved supplier list (ASL).
• Represent Cortland Biomedical as expert in the properties and performance of biomedical textile fibers.
• Support the creation and validation of test methods for the analysis of design concepts.
• Ensure project compliance with all ISO 13485 requirements outlined in Cortland Biomedical's Quality Management System. Provide continuous improvement ideas and solutions, in line with Quality initiatives.
• Develop new technological solutions to manufacturing challenges including identification of new equipment and use of digital tools, where applicable.
• Support transfer of new product development processes to commercial production.
• Participate in continuous improvement to improve processes, eliminate problems, streamline operations, or other areas as defined by management.
• Expand Cortland Biomedical's expertise in state-of-the-art engineering, manufacturing methods, and test methods through technical journals, seminars, advance degree programs, etc.
• Comply with and participate in safety protocols and initiatives.
• Additional tasks as assigned.

Skills and Competencies

• Knowledge of the physical and mechanical characteristics of polymers, fibers, yarns, and fabrics preferred
• Experience with documentation and traceability requirements for highly regulated industries preferred
• Effective verbal communication skills and comfortable interacting with team members, customers, and vendors at all levels
• Effective technical writing skills consistent with writing engineering reports and quality management system documentation
• Demonstrated creative problem solving and effective engineering decision-making skills
• Experience with Enterprise Resource Platforms (ERP) a plus
• Demonstrated ability to work well independently and as a team member
• Self-starter able to work under minimal supervision
• Capable of generating and delivering internal and external presentations at all levels

Education and Experience

BS Degree in Mechanical, Textile or Biomedical Engineering, or related degree from an accredited university

Minimum of 5 years of experience, 10 years+ preferred, in an engineering function within a manufacturing environment - especially in highly regulated industries (medical device, energy, aerospace, automotive, etc.), medical textiles or medical device preferred.

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 Contacts/Clients

Sales Engineers

Process Engineers

Manufacturing Engineers

Quality Engineers

External Customers