Technical Writer (NO C2C)

Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an Technical Writer

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NOTE: THIS IS AN ONSITE ROLE & ONLY W2 CANDIDATES (NO C2C/1099)

*** Candidate must be authorized to work in USA without requiring sponsorship ***

Position: Technical Writer (Job ID # CFNJP00051004)

Location: San Diego CA 92130

Duration: 12 months + Strong Possibility of Extension

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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 guide, 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, in addition to 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 and to suggest changes to enhance a document's 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 s 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, business units (corporate and international), and possesses a high degree of flexibility/selectivity in prioritizing business unit 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. Strong background in supporting regulatory requirements to ensure adherence to regulatory guidelines.
• Demonstrated ability to be highly collaborative 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 effectively manage the delivery of prioritized tasks.
• Ability to demonstrate a high level of initiative to gather information for developing documentation.
• Ability to work independently with minimal supervision.
• Effective at thinking independently and solving problems with product core team members.
• Ability to work under compressed deadlines and must be able to deal with unresolved situations, frequent project changes, delays, or other events.
• 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 enterprise resource planning (ERP) system is a plus.
• Experience in version control systems (VCS) such as, Perforce, Apache Subversion, Microsoft Team Foundation Server, or 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, standard editorial and proofreading symbols).
• Knowledge and experience with desktop publishing (DTP) software applications (MadCap Flare, Adobe FrameMaker, Adobe InDesign, Adobe Illustrator, XML, DITA) as applicable for technical documentation.

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If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you. We're driven, people driven.

Bhupesh Khurana

Senior Technical Recruiter

Email:

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients businesses forward.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.