Process Engineer

2 days ago


Orange, New Jersey, United States Enerpac Tool Group Full time
Job Title: Process Engineer

Cortland Biomedical is seeking a highly skilled Process Engineer to join our team. As a Process Engineer, you will be responsible for designing and developing 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 that meet and exceed customer expectations.

Key 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, and advance degree programs.
Requirements:
  • Effective working knowledge of mechanical engineering fundamentals.
  • Familiarity with the physical and mechanical characteristics of polymers, fibers, yarns, and fabrics is 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) is 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 is 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.).
Work Environment:

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

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.


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