ektello is hiring: Spec 2, Technical Writing in San Diego

Overview

Technical Writer – Local candidates only - San Diego, CA

Duration: 13 months possible for extension. Conversion to direct is TBD.

Pay: $40-46.50 /hr

Onsite/Hybrid: TBD

Job Summary

The Technical Writer will be responsible for developing, writing, and maintaining comprehensive technical documentation for our Class II medical devices. This role requires a detail-oriented professional with strong writing skills and a deep understanding of regulatory requirements. The ideal candidate will have extensive experience in the medical device industry and the ability to work effectively with cross-functional teams.

Key Responsibilities

• Create, edit, and maintain customer and internal facing technical documentation, including user manuals, installation guides, troubleshooting guides, and upgrade/downgrade instructions for various country regulatory submissions.
• Ensure all documentation meets regulatory requirements, industry standards, and company policies.
• Create illustrations, flow charts, diagrams, line art, and product photos for both quality and technical documentation. Provide recommendations to engineers on optimizing engineering data expressed in graphs, illustrations, and tables to ensure clarity and consistency.
• Collaborate with engineering, quality assurance, regulatory affairs, clinical/medical affairs, marketing, customer support, and other departments to gather information and ensure accuracy and completeness of documentation; suggest changes to enhance readability, clarity, conciseness, and style. Also collaborate with subject matter experts in the review and development of instructions-for-use (IFU) design specifications as part of the product quality documentation.
• Review and edit technical documents for clarity, accuracy, and compliance.
• Develop and implement documentation standards, best practices, and style guides to ensure consistency and quality.
• Communicate effectively with all levels of management and business units, with a high degree of flexibility in prioritizing deliverables to meet company goals.
• Stay current with industry trends, regulatory changes, and best practices in technical writing and medical device documentation.
• Provide guidance and mentorship to junior technical writers and other team members.
• Manage fast-moving documentation projects, including timelines, resources, and deliverables.
• Participate in, conduct, and drive cross-functional team meetings to provide input on documentation requirements and timelines.

Qualifications

• Experience working in a regulated industry such as medical devices or pharmaceuticals.
• Extensive experience with regulatory compliance processes and supporting regulatory requirements to ensure adherence to guidelines.
• Strong collaboration skills with marketing, clinical, quality, and regulatory reviewers.
• Five or more years writing and editing hardware/software user guides (print and online) and other technical product documentation.
• Ability to manage the delivery of prioritized tasks and work independently with minimal supervision.
• Ability to work under compressed deadlines and adapt to project changes or delays.
• Ability to handle multiple projects with excellent follow-up and project management skills.
• Familiarity with electro-mechanical concepts and software application usage.
• Experience in device labeling and/or packaging content development.
• Familiarity with large company engineering change control processes and Agile software development methodologies.
• Experience with SAP, Oracle, or similar ERP systems is a plus.
• Experience with version control systems (e.g., Perforce, Subversion, TFS, GitHub).
• Knowledge of photography and photo editing software such as Adobe Photoshop.
• Proficiency in electronic and hard copy markup (Acrobat, tracked changes in Word, standard editorial/proofreading symbols).
• Knowledge of desktop publishing (DTP) software (MadCap Flare, FrameMaker, InDesign, Illustrator, XML, DITA) as applicable to technical documentation.

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