$40K - 60K a year
Develop and maintain manufacturing documentation, ensure regulatory compliance, coordinate training, and support process optimization in a regulated manufacturing environment.
High school diploma with 2+ years in regulated manufacturing, preferably medical devices, knowledge of FDA, ISO, GMP, ERP systems, and lean manufacturing principles.
1st Shift: Mon - Fri 8AM - 5PM What you will do: 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. Key Responsibilities • Standard Work Instruction Drafting: Develop, revise, and maintain clear and compliant work instructions aligned with FDA and ISO standards. • LOTO (Lockout/Tagout) Procedure Authoring: Create and update equipment-specific LOTO procedures to ensure employee safety and regulatory compliance. • Control Plan Updates: Collaborate with engineering and quality teams to maintain accurate control plans reflecting current process capabilities and risk mitigation strategies. • Process Change Order Routing: Manage the documentation and routing of PCOs, ensuring timely review, approval, and implementation across cross-functional teams. • Training Management: Coordinate and track operator training for new processes, equipment, and quality procedures; maintain audit-ready records. • Time Studies: Conduct detailed time studies to support labor standard development, identify inefficiencies, and assist in line balancing efforts. • Router Management: Maintain accurate manufacturing routers in the ERP system, ensuring alignment with current BOMs, work instructions, and labor standards. What you will need: Required Qualifications • High school diploma or equivalent. • 2+ years of experience in a regulated manufacturing environment, preferably medical devices. Preferred Qualifications • 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. Pay rate will not be below any applicable local minimum wage rates.
This job posting was last updated on 10/6/2025