MillenniumSoft Inc
Senior Technical Writer - Req Exp in Medical devices or pharmaceuticals Industry
MillenniumSoft Inc, San Diego, California, United States, 92189
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)
Job Description
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.
Qualifications
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, GitHub).
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 (MadCap Flare, Adobe FrameMaker, Adobe InDesign, Illustrator, XML, DITA).
Preferred Skills
Experience with SAP, Oracle, or similar ERP system.
Experience with version control systems.
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Job Description
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.
Qualifications
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, GitHub).
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 (MadCap Flare, Adobe FrameMaker, Adobe InDesign, Illustrator, XML, DITA).
Preferred Skills
Experience with SAP, Oracle, or similar ERP system.
Experience with version control systems.
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