Biomedical Process Engineer II - Textile Manufacturing

enerpac; Munsons Corners (NY); On-site; USD 86,000 - 130,000; Full time

Job summary

Enerpac Tool Group in Cortland, NY is seeking an engineer to design and develop biomedical textile products and processes, manufacturing methods, techniques and procedures to meet and exceed customer expectations.

The role focuses on process development for medical device components, transfer to production, and compliance with QMS standards, including clean room manufacturing and documentation for IQ/OQ/PQ testing.

Qualifications

• 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.).

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.
• <10% domestic and international travel in support of customers, engineering projects, site acceptance tests and training

Skills

Mechanical eng basics

Polymers & fabrics

Verbal communication

Technical writing

Creative problem solving

ERP experience

Independent working

Self-motivated

Presentation skills

AutoCAD/SolidWorks

Communication/adaptability

Education

BS Degree in Mechanical or Textile Engineering

Tools

AutoCAD

SolidWorks

ERP systems

Job description

Enerpac Tool Group in Cortland, NY is seeking an engineer to design and develop biomedical textile products and processes, manufacturing methods, techniques and procedures to meet and exceed customer expectations.

The role focuses on process development for medical device components, transfer to production, and compliance with QMS standards, including clean room manufacturing and documentation for IQ/OQ/PQ testing.