**Company Overview**Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve "better" now, not some day.At Outset we're revolutionizing an industry and changing lives. We're impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo® Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We're giving providers time back to focus on patient care. And we're giving patients the power to take control of their life and get back to enjoying the things they love.**Position Overview**Seeking a creative, self-starter with strong Technical Writer skills to develop technical documentation strategy and content for our novel dialysis machine and supporting products. This person will partner closely with R&D, Marketing, and Regulatory to translate our unique value proposition in a way that resonates with both patients and health care professionals alike.**Job Functions and Responsibilities**- Create and maintain technical documentation for medical devices, including user manuals, instructions for use (IFUs), and service manuals- Collaborate with cross-functional teams including engineers, regulatory affairs, and quality assurance to gather information and ensure accuracy of documentation- Translate technical specifications and data into clear, concise, and user-friendly content- Ensure compliance with regulatory requirements and industry standards (e.g., FDA, ISO)- Conduct thorough research to understand product functionality and features- Review and revise documentation based on feedback from stakeholders and users- Manage documentation version control and updates throughout product lifecycle- Assist in the creation of training materials and presentations for internal and external stakeholders- Stay updated on industry trends, regulations, and best practices in technical writing for medical devices**Required Qualifications**- Bachelor's degree in technical writing, English, communications, Engineering or a related field- Strong writing skills with the ability to convey complex technical information clearly and concisely- Experience in technical writing, preferably in the medical device or healthcare industry- Knowledge of medical device regulations and standards (e.g., FDA regulations, ISO 13485)- Ability to understand and interpret technical specifications and engineering documents- Proficiency in document formatting and editing software (e.g., Microsoft Word, Adobe Acrobat)- Experience working with Adobe (RoboHelp, Photoshop, Illustrator, Snagit)- Attention to detail and accuracy in documentation- Advanced English (Written and verbal)- Excellent research skills to gather information from various sources- Adaptability to meet tight deadlines and handle multiple projects simultaneously**Desired Qualifications**- Experience with LMS systems- Markdown editors (Typora, Visual Studio Code, Markdown Pad)- Version control software (GitHub, Bitbucket)- Screen capture tools- Snagit- Camtasia- OBS Studio**Company Culture**At Outset, we believe every person matters. Every Outsetter, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with intelligent speed. Our team expects nothing less than our best display of strengths and skills, and we find joy in working together for a common goal. At Outset, we believe that curiosity, ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers.And this doesn't happen by accident. It starts with our live onboarding program, Bold Beginnings, which serves as an incubator for cross-functional team-building, an immersion in Outset's history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry. In SPARK!, people managers across functions come together to master three pivotal conversations: 1) the priority conversation, 2) the performance conversation, and 3) the growth conversation. They do this in an environment that challenges, supports, and broadens mindsets.We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU, our future Outsetter. At Outset, we've designed a professional world that our employees
