medical devices Technical Writer - Framemaker & Flare MDR

Please contact Abdul on "" OR email me at ""

Intake notes:

Position Overview

• Type: New role, Start Date: Target is October 6, 2025,
• Purpose: To create customer-facing documentation for a complex medical device.

Work Arrangement

• Hybrid: Preferred, but flexible depending on the candidate.
• Remote Work: Could be up to 90% remote for highly qualified candidates.
• Location Preference: Initially targeting Boston-area candidates, but open to nearby states (NH, VT, ME) for exceptional profiles.
• Local candidates from the Boston Area preferred, however remote candidates can apply
• Open to part-time and full-time applicants

Interview Process

• Format: o Initial phone screens. o One half-day in-person interview with multiple team members.

o May be lighter if candidate provides strong samples of previous work (e.g., published user manuals).

Job Description:

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.

As a Contract Technical Writer, you will be responsible for:

• 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.

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers:

• 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.

Required skills to have for the success of this role:

• 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.

Experience Requirements

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

Must-Have Skills/Experience

1. Experience writing or leading creation of user guides for complex electromechanical or software-based medical devices.
2. Background in the medical device industry.
3. Ability to work independently.
4. Familiarity with tools such as:

o Adobe FrameMaker

o MadCap Flare

o Microsoft Word

Nice-to-Have

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

Collaboration

• Will work closely with:

o Systems Engineering

o Product Management

o Usability Teams

Please contact Abdul on "" OR email me at ""