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R&D Process Development Engineer

1 month ago

Bloomington, Indiana, United States Entegee Full time
Job Summary

We are seeking a highly skilled R&D Process Development Engineer to join our team at Entegee. As a key member of our R&D team, you will be responsible for designing and optimizing processes for manufacturing new medical devices.

Key Responsibilities:

  • Design and optimize processes for new medical device manufacture
  • Identify and evaluate innovative processing options based on product attributes
  • Execute cost-effective systems to enhance processing speed and quality while ensuring compliance with regulations
  • Collaborate with R&D team, Operations, and Production engineering for effective project completion
  • Responsible for process documentation (PFMEAs, Production Instructions, Drawings)
  • Define, identify, and procure new equipment for manufacturing processes
  • Adhere to Quality Management System processes to meet regulatory requirements

Requirements:

  • Bachelor's degree in Engineering
  • Must be a US Citizen
  • 3-5 years of solid engineering experience
  • Experience in Class II/III medical device manufacturing or GMP regulated environment
  • Knowledge of process validation, design for manufacturing, statistics, and lean manufacturing principles
  • Familiarity with ISO 13485/FDA practices and GMP standards
  • Experience with CREO and process development

Preferred Skills:

  • Knowledge of 3D Modeling software (Creo, SolidWorks, etc.)
  • Proficiency in Microsoft Office Software (Word, Excel, Visio, PowerPoint, MS Project)

Benefits:

  • Medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, and a 401K plan
  • Equal Opportunity Employer/Veterans/Disabled

Company Description:

Entegee specializes in custom automation projects and is a major player in the world of controls and robotic solutions around the world.