Technical Writer

JOB SUMMARY:

The Technical Writer will be responsible for creating, editing, and maintaining clear, accurate, and user-friendly documentation for medical devices, equipment, and processes. This role requires collaboration with engineers, product managers, quality assurance teams, and regulatory specialists to ensure all materials meet industry standards and support our commitment to excellence in healthcare technology.

ESSENTIAL FUNCTIONS:

• Develop and write technical documentation, including user manuals, installation guides, maintenance instructions, and standard operating procedures (SOPs) for medical devices and manufacturing processes.
• Translate complex technical information into concise, accessible content for diverse audiences, including healthcare professionals, technicians, and regulatory bodies.
• Ensure all documentation complies with regulatory requirements (e.g., FDA, ISO 13485) and company quality standards.
• Collaborate with subject matter experts (SMEs) to gather technical details and validate content accuracy.
• Edit and revise existing documentation to reflect product updates, process improvements, or regulatory changes.
• Create visual aids, such as diagrams, flowcharts, and illustrations, to complement written content.
• Manage multiple projects simultaneously, adhering to deadlines and maintaining consistency across all deliverables.
• Participate in product development reviews to provide input on documentation needs and usability.

QUALIFICATIONS:

• Bachelor’s degree in Technical Writing, English, Communications, Biomedical Engineering, or a related field.
• 2 years of experience in technical writing, preferably in the medical device, healthcare, or manufacturing industry.
• Strong understanding of medical terminology, manufacturing processes, and regulatory standards (e.g., FDA, CE Mark, ISO).
• Proficiency in documentation tools such as Microsoft Office, Adobe Acrobat, and technical writing software (e.g., MadCap Flare, FrameMaker).
• Excellent written and verbal communication skills with a keen eye for detail.
• Ability to work independently and collaboratively in a fast-paced, cross-functional environment.
• Experience with visual design tools (e.g., Adobe Illustrator, Visio) is a plus.

PREFERRED SKILLS:

• Knowledge of Good Documentation Practices (GDP) and quality management systems (QMS).
• Familiarity with medical device development lifecycle and risk management documentation.

Prior experience interpreting engineering drawings or schematics

WORKING CONDITIONS

Good working conditions in office environment. Work is primarily performed in an office setting with extended periods at a computer and regular exposure to manufacturing and warehouse areas. The nature of the work has frequent interruptions; contact with FDA, ISO, Clients and interoffice staff.

Job Type: Full-time

Pay: $50,000.00 - $60,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person

Salary : $50,000 - $60,000