Technical Writer

About the position

As a Technical Writer at SHL Medical, you will be responsible for creating clear and user-friendly documentation for various internal processes, including Standard Operating Procedures (SOPs) and Work Instructions. This role involves close collaboration with subject matter experts, engineers, and production teams to ensure that all documentation meets company and regulatory standards, including ISO 13485 and FDA regulations.

Responsibilities

• Develop, revise, and standardize SOPs, Work Instructions, and other technical documentation.
• Collaborate with various departments to gather information and ensure the accuracy of technical documents.
• Translate complex technical concepts into easily understandable content for diverse audiences.
• Ensure all documentation complies with company policies, industry standards, and regulatory requirements, including ISO 13485, FDA 21 CFR Part 820, and GMP.
• Review and edit existing documents to ensure they are current and reflect operational changes.
• Maintain a centralized repository of all technical documents and ensure easy accessibility.
• Assist in training and onboarding by providing clear and comprehensive documentation for procedures.
• Perform other related duties as assigned.

Requirements

• Bachelor's degree in Technical Writing, English, Engineering, or related field.
• 2-5 years proven experience as a Technical Writer or related experience, preferably in a manufacturing, engineering or regulated environment.
• Excellent written and verbal communication skills with attention to detail.
• Strong organizational skills with the ability to manage multiple projects simultaneously.

Nice-to-haves

• Experience in the medical device industry.
• Knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP Standards.
• Familiarity with ISO 14971 for risk management in medical device production.

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Vision insurance