Technical Writer - Medical Device #2902

About ECI ECI’s mission is to be the global leader of professional consulting services for the life sciences industry.

Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value.

ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects.

Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

The Technical Writer is responsible for creating, editing, and maintaining high-quality documentation that supports the development, regulatory approval, and use of medical devices.

This includes user manuals, design documentation, labeling, and regulatory submissions in compliance with global standards.

• Develop and maintain technical documentation such as:
• User manuals and instructions for use (IFU) Design history files (DHF) Device master records (DMR) Standard operating procedures (SOPs)
• User manuals and instructions for use (IFU)
• Design history files (DHF)
• Device master records (DMR)
• Standard operating procedures (SOPs)
• Ensure documentation complies with regulatory standards such as FDA and ISO (e.g., ISO 13485, ISO 14971)
• Collaborate with cross-functional teams (engineering, quality, regulatory, clinical)