Job Description

Who We Are:

Mobius Imaging is the premier developer and supplier of Airo TruCT, the largest inner bore mobile diagnostic and intraoperative CT imaging system This is an exciting opportunity to work on an autonomous surgical and medical robot. It's a huge and exciting merge of robotics, imaging, and navigation. Our team functions very much like a start-up within an established stable and growing business of Stryker. The team is very focused with a fair amount of autonomy to develop ideas like a start-up would but with the backing and stability of a larger company.

Who We Want:

* Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

* Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

* Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What You Will Do:

* You will develop, write, edit and revise product Instructions For Use (IFUs) that provide instructions and information detailing user/patient safety, product features, procedures for handling, maintenance, etc.

* Develops (writes, edits, revises) IFUs for a variety of complex medical devices with inputs from (design engineers, regulatory affair reps, product safety engineers, clinical science engineers, and other subject matter experts) to ensure accuracy of information and compliance with FDA, MDD and as appropriate, additional requirements

* Actively participates in new product development meetings to provide insights on best quality outcomes for instructional material strategies and resolve related challenges

* Organizes IFU content and completes writing assignments according to established guidelines for order, content, clarity, conciseness, format, style and terminology

* Conceptualizes (and may procure) graphical elements (tables, charts, illustrations, etc.) that support instructional information

* Collaborate with label/marking designers in functional area to align label/marking and IFU content

* Attends product usability studies to observe operating procedures. May provide inputs for product design improvements, simplification of graphical user interface, and feature markings

* May conduct usability testing on IFUs to increase usability of instructional information

* Helps establish standardized text, glossaries and nomenclature, style guide and templates, and structure of instructional information

What You Need:

* Bachelor's degree in engineering, business, technical writing, or a related discipline

* 2+ years of experience; medical device, pharmaceutical or similarly regulated environment preferred

* Proficiency in Adobe Creative Suite, MS Office tools and Windchill, preferred

* Working knowledge of FDA, MDD labeling requirements preferred

* Knowledge of printing and graphic reproduction practices, preferred

* Knowledge of XML publishing, preferred

* You may be asked to provide a writing sample during the interview process