Job Description

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide The opportunity below is with one of our clients, a leading global medical technology company. This organization provides a wide range of diagnostic imaging and laboratory diagnostics, as well as advanced therapies and digital health services. Its solutions span prevention and early detection through diagnosis, treatment, and follow-up care, empowering healthcare providers worldwide.

Job Title: Technical Writer/Editor 4

Location: Newton, MA, 02466

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Hybrid

Shift: 9.00AM-5.00PM

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 the client:
• 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.

Important notes:

• Local candidates from the Boston Area preferred, however remote candidates can apply
• Open to part-time and full-time applicants
• At the client, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry.
• What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services.
• We recognize that taking ownership of our work allows both us and the company to grow.
• We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
• Experience Requirements

Minimum:

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

Must-Have Skills/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.

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Job Tags

Full time, Contract work, Temporary work, Part time, Local area, Remote work, Worldwide, Flexible hours, Shift work,

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