Computer Software Assurance SME - Medical Device #4145

Brief DescriptionAbout ECIECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.About The RoleThe Senior Technical Writer is responsible for creating, editing, and maintaining high-quality documentation that supports the development, regulatory approval, and use of medical devices. This includes user manuals, design documentation, labeling, and regulatory submissions in compliance with global standards.What You'll Do Develop and maintain technical documentation such as:User manuals and instructions for use (IFU)Design history files (DHF)Device master records (DMR)Standard operating procedures (SOPs)Ensure documentation complies with regulatory standards such as FDA and ISO (e.g., ISO 13485, ISO 14971)Collaborate with cross-functional teams (engineering, quality, regulatory, clinical)Translate complex technical and scientific information into clear, user-friendly contentSupport regulatory submissions (e.g., 510(k), CE marking)Maintain document control processes and versioningReview and edit documents for accuracy, consistency, and complianceParticipate in risk management and usability documentationWhat We Look For Bachelor’s degree in Technical Writing, Engineering, Life Sciences, or related field2–5+ years of experience in technical writing, preferably in medical devices or healthcareStrong understanding of medical device regulations and standardsExcellent writing, editing, and communication skillsFamiliarity with document management systems and tools.Experience with regulatory frameworks such as:21 CFR Part 820EU MDRKnowledge of usability engineering and risk management processesExperience with tools like:Microsoft Word, Adobe AcrobatXML/DITA authoring systemsAbility to manage multiple projects and deadlinesECI is an equal opportunity employer.All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship from ECI another 3rd party vendor.