About The Position

The Engineering Technician - Technical Writer plays a vital part in ensuring product quality, regulatory compliance, and operational efficiency through documentation control, process optimization, and training coordination.

Requirements

  • High school diploma or equivalent.
  • 2+ years of experience in a regulated manufacturing environment, preferably medical devices.

Nice To Haves

  • Associate degree in Engineering Technology, Industrial Engineering, or related field.
  • Understanding of lean manufacturing principles.
  • Working knowledge of FDA regulations, ISO, and GMP practices.
  • Proficiency with ERP systems (e.g., SAP, JDE), Microsoft Office, and document control platforms.

Responsibilities

  • Develop, revise, and maintain clear and compliant work instructions aligned with FDA and ISO standards.
  • Create and update equipment-specific LOTO procedures to ensure employee safety and regulatory compliance.
  • Collaborate with engineering and quality teams to maintain accurate control plans reflecting current process capabilities and risk mitigation strategies.
  • Manage the documentation and routing of PCOs, ensuring timely review, approval, and implementation across cross-functional teams.
  • Coordinate and track operator training for new processes, equipment, and quality procedures; maintain audit-ready records.
  • Conduct detailed time studies to support labor standard development, identify inefficiencies, and assist in line balancing efforts.
  • Maintain accurate manufacturing routers in the ERP system, ensuring alignment with current BOMs, work instructions, and labor standards.

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What This Job Offers

Job Type

Full-time

Industry

Miscellaneous Manufacturing

Education Level

High school or GED

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