Technical Writer II

Job Title: Technical Writer II Location: Middletown, VA, 22645 Duration: 9 Months+ (Possible Extension) Job Description: We are looking for innovative candidates to be a key contributor in supporting the development of software product that impact on patient lives. The candidate will support R&D with primary responsibility for the hands-on management of documentation supporting software diagnostics product development and on-market product improvements. This candidate will work closely with cross-functional teams to write, edit, review and finalize technical documents required for software products which includes but not limited to documents involving design control deliverables, verification and validation protocols and reports, and other documents associated with the phase-gate development of new products and the transfer of products from R&D to production. This technical writer role will be a trusted resource and a key core team member in a multi-functional, multi-site project team. This position will be responsible for developing the documents for the software application according to IEC 62304 and 21 CFR Part 11 environment. Major Responsibilities: Follow design control for new software product development per FDA and international guidelines Build Design History File for new software product developmentDevelop design control documentation, including Design and Development Plans, Development Reports, Test Method and Process Validation Protocols, FMEAs Manage document change control Develop Standard Operating Procedures Maintain integrity of documents to comply with and be incorporated into the company's quality procedures. High quality, well formatted, clear documentation following GDP (good documentation practices) is mandatory. Development of customer-facing documentation e.g. user guides, training manuals Solicit, align, and incorporate feedback from diverse stakeholders. Education: Bachelors in related field plus 5 year of experience Qualifications: Excellent verbal and written communication skills Skills in Microsoft Office Ability to work in a fast-paced environment Ability to drive project progress per assigned task Must be highly collaborative, have the ability to work within a diverse team, and contribute to a supportive, positive work environment both within the team and in the greater site-wide community. Knowledge of FDA regulations for software product development.

Created: 2026-03-04