Biomedical Textile Engineer: Cleanroom Manufacturing

enerpac; Munsons Corners (NY); Hybrid; USD 97,000 - 145,000; Full time

Job summary

Cortland Biomedical in Cortland, NY, part of Enerpac Tool Group, is seeking a Mechanical/Textile Biomedical Engineer to design and develop biomedical textile products and manufacturing processes, focusing on component processing to meet customer expectations.

You will create and optimize PFMEAs, IQ/OQ/PQ protocols, and QMS documentation, transfer processes to production, and collaborate across engineering, manufacturing and suppliers. Travel is <10% domestically and internationally.

Qualifications

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

Responsibilities

• Develop textile forming and finishing processes for new medical device products.
• Document detailed manufacturing processes to support new product development.
• Implement and optimize processes for manufacturing in a clean room environment.
• Create PFMEAs, IQ/OQ/PQ, 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.
• Transfer of new product development processes to commercial production.
• Support the creation, audit and review of test standards and methods for analysis of design concepts and component assemblies.
• Support 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 to aid manufacturing processes.
• Expand Cortland Biomedical’s expertise through technical journals, seminars, and advanced degree programs.
• <10% domestic and international travel in support of customers, engineering projects, site acceptance tests and training

Skills

Verbal communication

Technical writing

Creative problem solving

CAD (AutoCAD/SolidWorks)

Independent worker

ERP experience

Presentation skills

Materials knowledge

Education

BS Degree in Mechanical, Textile or Biomedical Engineering

Tools

AutoCAD

SolidWorks

ERP Systems

Job description

Cortland Biomedical in Cortland, NY, part of Enerpac Tool Group, is seeking a Mechanical/Textile Biomedical Engineer to design and develop biomedical textile products and manufacturing processes, focusing on component processing to meet customer expectations.

You will create and optimize PFMEAs, IQ/OQ/PQ protocols, and QMS documentation, transfer processes to production, and collaborate across engineering, manufacturing and suppliers. Travel is <10% domestically and internationally.