Process Engineer I

1 week ago


Huntersville, North Carolina, United States Safeguard Medical Full time
Job Summary

The Process Engineer I at Safeguard Medical supports the development, sustainment, and validation of manufacturing processes for medical devices. This role involves determining process flow, developing fixtures and tooling, and generating engineering and production documentation.

Key Responsibilities:

  • Develop and maintain timelines for project tasks throughout the process development cycle.
  • Act as a technical liaison between cross-functional teams and production facilities for new and existing products and processes.
  • Implement product and process changes using the change control process.
  • Execute validations (IQ/OQ/PQ) in accordance with FDA and ISO harmonized standards.
  • Support production transfers, including production floor layout and facility planning activities.
  • Run laboratory equipment and implement preventative maintenance plans.
  • Interface with quality and development engineers concerning inspection procedures and gages.
  • Create and maintain accurate documentation of process specifications and work instructions.
  • Conduct time studies and develop standard work and routing times for processes.

Requirements:

  • Bachelor of Science degree in Mechanical Engineering and minimum 1-3 years' experience in the field or a related area.
  • Technical knowledge and understanding of the medical device industry.
  • Computer literate with experience in Microsoft Office applications.
  • Intermediate level 3D and 2D computer aided design software experience required.

Competencies:

Demonstrates ownership and accountability, ability to plan, execute, control, and deliver, communicate effectively, perform repetitive tasks, multitask and prioritize, apply knowledge and understanding of the medical industry, lead and influence others effectively and without authority.

Work Environment:

The noise level in the work environment is usually quiet to moderate. Occasionally this position will be in a lab or machine shop environment where the noise level will be loud.

This job description is not designed to cover an exhaustive list of duties. Other duties may be assigned and activities may change at any time with or without notice.


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