Technical Writer

Job Title: Technical Writer
Job Location: Newton MA - Could be up to 90% remote for highly qualified candidates.
Job Duration: 12 Months (possibility of extension)
Shift: 9:00AM - 5:00PM
Payrate: $65.00/ hr on w2

Job Summary:

• We are seeking a Contract Technical Writer to join our Endovascular Robotics business within Advanced Therapies.
• This role involves translating complex technical engineering processes and details into clear, accurate, and compliant documentation for a cutting-edge medical robotics system.
• We are a global technology leader in robotic-assisted vascular interventions.
• We believe the combination of endovascular robotics, image guidance and dedicated devices will change the way neurovascular procedures will be done in the future, enabling better outcomes, and enabling our customers to provide better access to care.

Key Responsibilities:

• Author and revise IFUs, operator manuals, installation manuals, service manuals, and quick reference guides in accordance with FDA, MDR, and ISO standards.
• Translate complex engineering concepts into clear, concise, and accessible documentation for clinical and technical audiences.
• Collaborate with cross-functional teams (engineering, regulatory, human factors, QA) to gather source material and verify/validate content.
• Maintain version control and traceability of documentation.
• Support risk management and design history file (DHF) documentation as needed.
• Assist in developing templates, style guides, and documentation standards.

Preferred Experience and Skills:

• Familiarity with usability testing, risk management, and regulatory documentation (FDA 21 CFR Part 820, ISO 13485).
• Experience with authoring tools (e.g., Adobe FrameMaker, MadCap Flare, Microsoft Word) and content management systems.
• Experience authoring IFU/operator manuals for highly complex medical devices.

Education and Experience Requirements:

• Bachelor’s degree in Engineering, Technical Communication, Life Sciences, or related field.
• 5+ years of experience in technical writing, preferably in medical devices or regulated industries.
• Strong attention to detail, organization, and ability to manage multiple projects.
• Excellent written and verbal communication skills.

Additional Qualifications:

• Minimum: 8+ years preferred (initially listed as 5+).
• Ideal Candidate: Someone who can work independently with minimal oversight.

Specific Experience:

• Experience writing or leading creation of user guides for complex electromechanical or software-based medical devices.
• Background in the medical device industry.
• Ability to work independently.
• Familiarity with tools such as:
  • Adobe FrameMaker
  • MadCap Flare
  • Microsoft Word

Nice-to-Have:

• Experience with robotic systems.
• Experience developing training materials.

Collaboration:

• Will work closely with:
  • Systems Engineering
  • Product Management
  • Usability Teams.

Important Notes:

• Local candidates from the Boston Area preferred, however remote candidates can apply.
• Open to part-time and full-time applicants.

Interview Process Format:

• Initial phone screens.
• One half-day in-person interview with multiple team members.
• May be lighter if candidate provides strong samples of previous work (e.g., published user manuals).