Senior Technical Writer - Req Exp in Medical devices or pharmaceuticals Industry

Senior Technical Writer – Medical Devices

Location:

San Diego, CA | Duration: 12 months |

Hours:

40/week |

Shift: 1st | Client:
Medical Devices Company | Category:
Professional | Level: Senior |

Employment Type:

Contract on W2 (US Citizens / Green Card / EAD / OPT / CPT)

• Work with engineers, product managers, and other subject matter experts to develop technical product and process support documentation.
• Demonstrate a basic understanding of technical product support documentation.
• Develop, write, and maintain comprehensive technical documentation for Class II medical devices.
• Ensure all documentation meets regulatory requirements, industry standards, and company policies.
• Create illustrations, flow charts, diagrams, line art, and product photos for technical documentation.
• Collaborate with engineering, quality assurance, regulatory affairs, clinical/medical affairs, marketing, customer support, and other departments to gather information and ensure accuracy and completeness.
• Review and edit technical documents for clarity, accuracy, and compliance.
• Develop and implement documentation standards, best practices, and style guides.
• Communicate effectively with all levels of management and business units.
• Stay current with industry trends, regulatory changes, and best practices.
• Guide and mentor junior technical writers and other team members.
• Manage fast-moving documentation projects, including timelines, resources, and deliverables.
• Participate in cross‑functional team meetings to provide input on documentation requirements and timelines.

• Experience in a regulated industry such as medical devices or pharmaceuticals.
• Extensive experience with regulatory compliance processes.
• Strong background supporting regulatory requirements.
• Collaborative experience 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.
• Effective project management and prioritization skills.
• High initiative in gathering information for developing documentation.
• Ability to work independently with minimal supervision.
• Problem‑solving skills with product core team members.
• Ability to handle compressed deadlines and frequent project changes.
• Excellent follow‑up and project management skills handling multiple projects.
• 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 (bonus).
• Experience with version control systems (Perforce, Subversion, Team Foundation, Git Hub).
• Knowledge of photography and photo editing software such as Adobe Photoshop.
• Skilled in both electronic and hard copy markup (Acrobat, tracked changes in Microsoft Word, editorial and proofreading symbols).
• Knowledge and experience with desktop publishing (Mad Cap Flare, Adobe Frame Maker, Adobe InDesign, Illustrator, XML, DITA).

• Experience with SAP, Oracle, or similar ERP system.
• Experience with version control systems.