Technical Writer II

Technical Writer IIThe Technical Writer II supports manufacturing operations by creating, revising, and releasing technical documentation used in production environments for a highly regulated medical device organization. This role works closely with Manufacturing, Process Engineering, R&D, Mechanical Engineering, Operations, Quality, and Document Control teams to translate complex engineering concepts and manufacturing processes into clear, compliant, and user-friendly documentation. The position offers the opportunity to contribute directly to production operations, equipment qualifications, and process improvements within an innovative and fast-growing manufacturing engineering environment.ResponsibilitiesCreate, revise, and release manufacturing documentation, including work instructions, standard operating procedures (SOPs), manufacturing procedures, process documentation, and technical reports used on the production floor.Author equipment qualification documentation such as user requirement specifications (URS), installation qualification (IQ), and operational qualification (OQ) protocols to support validation and equipment readiness.Translate complex engineering and manufacturing concepts into clear, concise, and user-friendly documentation suitable for production personnel and cross-functional stakeholders.Gather information from subject matter experts, including engineers, scientists, manufacturing personnel, and quality teams, through interviews and collaborative working sessions.Document experimental designs, engineering data, and qualification results in formal technical reports and supporting documentation.Support document release activities through product lifecycle management (PLM) systems, including Oracle Cloud PLM and Agile PLM, ensuring proper routing, review, and approval of documentation.Prepare and manage change orders in alignment with document control and change management processes, ensuring accurate revision history and compliance with quality system requirements.Ensure all documentation complies with applicable regulatory requirements, including FDA and GMP expectations, as well as internal design controls and quality standards.Collaborate closely with Manufacturing, Process Engineering, R&D, Mechanical Engineering, Operations, and Document Control to align documentation with current processes, equipment, and design controls.Support manufacturing process development by capturing process steps, parameters, and controls in clear, structured documentation that can be used reliably on the production floor.Contribute to continuous improvement of documentation templates, standards, and processes to enhance clarity, consistency, and usability.Participate in cross-functional engineering initiatives by providing documentation support for new equipment, process changes, and validation activities.Assist in maintaining an organized and compliant document control system by adhering to established procedures for document creation, review, approval, and archiving.Essential SkillsMinimum 2+ years of experience in technical writing, manufacturing documentation, validation, quality, process engineering, or related technical environments.Proven experience creating and revising manufacturing process documentation in a production environment, including work instructions, SOPs, manufacturing procedures, and technical reports.Strong technical writing skills with the ability to translate complex engineering and manufacturing concepts into clear, user-friendly documentation.Experience authoring equipment qualification documentation such as URS, IQ, and OQ protocols.Experience documenting manufacturing processes used on production floors in a regulated environment.Ability to understand engineering concepts, manufacturing equipment, and experimental designs and accurately capture them in formal documentation.Strong communication skills with the ability to interview engineers and subject matter experts and synthesize information effectively.Familiarity with document control processes and change management systems.Knowledge of design controls, FDA expectations, and GMP requirements in a manufacturing context.Experience using PLM systems, including Oracle Cloud PLM and Agile PLM, for document release and change management.Additional Skills & QualificationsBachelor's degree in Engineering, Manufacturing, Life Sciences, Technical Communication, or a related technical field.Experience in regulated manufacturing environments, preferably within medical device manufacturing.Validation experience, including documenting qualification and validation activities, is highly valued.Background in manufacturing engineering, process engineering, validation, quality, or technical documentation.Ability to work effectively in cross-functional teams with Manufacturing, Process Engineering, R&D, Mechanical Engineering, Operations, Quality, and Document Control.Strong attention to detail and commitment to maintaining high documentation quality and compliance.Interest in supporting advanced manufacturing processes, equipment development, and cross-functional engineering initiatives.Motivation to work in a fast-growing, highly regulated environment with opportunities for extension and potential future conversion.Work EnvironmentThe role is based onsite in a manufacturing and engineering environment in San Diego, supporting manufacturing process development, production documentation, and equipment qualification activities. The Technical Writer II works in a highly regulated medical device manufacturing setting with established document control and quality system requirements, including FDA and GMP expectations and design controls. The position involves a combination of technical writing, documentation development, data collection, and frequent cross-functional interaction with Manufacturing, Process Engineering, R&D, Mechanical Engineering, Operations, Quality, and Document Control teams. Work is performed during standard business hours in support of a production-focused organization, providing exposure to advanced manufacturing processes, equipment development, and cross-functional engineering initiatives within a dynamic and innovative environment.Job Type & LocationThis is a Contract position based out of San Diego, CA.Pay and BenefitsThe pay range for this position is $40.00 - $42.00/hr.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan – Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a fully onsite position in San Diego, CA.Application DeadlineThis position is anticipated to close on Aug 20, 2026.