Engineering Technical Writer

Job DutiesWe are seeking an experienced Technical Writer / Labeling Specialist to support labeling development for medical devices. This individual will work cross-functionally to develop, update, and manage Instructions for Use (IFUs) and other labeling deliverables in compliance with regulatory standards and quality processes.Key Responsibilities / Day-to-Day Activities• Update and maintain Instructions for Use (IFUs) to align with cross-functional feedback, regulatory requirements, and quality standards.• Support PLM workflows, including approvals, translation coordination, and product launch activities (metadata management, print proofs, and distribution).• Collaborate with cross-functional teams to plan, develop, review, and finalize labeling from concept through product launch.• Plan, research, develop, and write medical device labeling content.• Manage multiple projects simultaneously (e.g., labeling updates and new product introductions).• Ensure compliance with Quality Management Systems (QMS) and product commercialization processes.• Conduct interviews with technical staff and stakeholders to gather documentation requirements.• Support Engineering Change Orders (ECOs) related to labeling.• Coordinate and track translation activities.• Develop documentation for regulatory submissions and audits (including CAPAs).• Collaborate with illustrators to develop supporting visuals and diagrams.• Contribute to project timelines and cost estimates.• Participate in department and cross-functional initiatives.Minimum Education Required• Bachelor's degree required.Minimum Experience RequiredTop Required Skill Sets• Strong collaboration, and excellent verbal and written communication skills (including technical writing).• Proficiency with authoring tools (e.g., Adobe InDesign, FrameMaker, XML tools).• Experience working in complex regulatory environments with robust quality systems.Qualifications• 5–10 years of relevant experience in technical writing, preferably in medical devices or regulated industries.• Strong understanding of regulatory documentation and labeling requirements.• Demonstrated ability to manage multiple projects and deadlines.• Experience working within PLM systems and quality/regulatory processes.ShiftFirst (Day)Number of Openings2Public Transportation AccessibleYesVeterans Encouraged to ApplyYesPhysical RequiredNoDrug Test RequiredYesCompensation$28.00 - $50.00 / HourlyPostal Code55112Job TypeContract (W2)Place of WorkOn-siteRequisition ID6750Job BenefitsHealth Insurance, Life Insurance, 401k retirement plan, paid sick timeApplication InstructionsIf interested and qualified, please submit your resume to careers@dr-group.com or visit our website to apply: http://dr-group.com/find-engineering-technical-jobs/