Technical Writer

Technical Writer – Kelly Engineering, Project Services

Largo, Florida.

Client in medical devices is seeking a detail-oriented Technical Writer to support biocompatibility compliance efforts driven by evolving EU MDR (European Union Medical Device Regulation) requirements. This contract role will focus on updating and documenting manufacturing process flows for approximately 130 technical files and nearly 500 catalog numbers related to our sports medicine disposable orthopedic devices.

• Review existing manufacturing documentation and collaborate with the engineering team.
• Identify and document all processes and materials used in the manufacturing of finished goods and subassemblies.
• Create detailed, end-to-end manufacturing process flow maps to support technical file updates and biocompatibility needs.
• Maintain a high level of accuracy and organization in updating technical documents as required for EU MDR compliance.

• Project will cover 132 technical files and about 500 catalog numbers.
• Each technical file is estimated to take approximately 10 hours (~1,300 hours total).
• Full-time, 40-hour work week.

• Quick learner who can “hit the ground running.”
• Experience in manufacturing environments is a plus but not required. Medical Devices strongly preferred.
• Detail-oriented with strong technical writing and process documentation skills.
• Effective communicator, comfortable collaborating with cross-functional teams.

The team will provide guidance and tools for our process mapping approach to ensure your success. Join us to play a critical role in meeting new EU MDR standards and ensuring the continued quality and compliance of innovative medical devices!