Senior Technical Writer

About Haemonetics

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

The Senior Technical Writer is responsible for authoring, revising, and maintaining end-user documentation for medical devices in compliance with applicable regulatory and quality system requirements. The ideal candidate has demonstrated experience working within FDA- and ISO-regulated environments and is highly proficient in MadCap Flare for structured, reusable content development. This individual operates with moderate independence and partners cross-functionally to ensure documentation accuracy, regulatory compliance, and consistency across product lines.

The Senior Technical Writer may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Performs large or complex portions of documentation projects across multiple product lines or specialization areas.
• Works on technically complex and high-impact projects and deliverables where ingenuity and basic business understanding is required.
• Creates, revises, and seeks approval of documentation and ensures consistency across documentation.
• Contributes to continuous improvement of templates, style guides, and publishing workflows.
• Contributes to the project strategy to meet target goals and milestones, evaluates resource allocation needs, and monitors project risks to determine the best mitigation path.
• Independently research issues outside of current technical writing knowledge and capability and selects the most efficient methods/techniques to achieve objectives.
• Identifies technical writing and medical device industry standards, processes, policies, practices, and tools including Standard Operating Procedures (SOP)s, industry best practices, style guides, templates, desktop publishing tools, and applicable regulations (Examples: FDA, CE Marking, and ISO).
• Applies knowledge to a variety of assignments reflecting proficiency in a broad range of complex topics.
• Demonstrates deep/advanced knowledge of technical writing theory and methods.
• Translates specialized product needs, customer needs, operational policies and processes, and product use into feasible documentation requirements and recommendations.
• Researches and analyzes data relating to the development and distribution of technical documentation.
• Demonstrates advanced project management skills, systems knowledge/skills, and basic business understanding.
• Coordinates work primarily across project team(s), related groups, or within the department.
• Communicates proactively and effectively at all levels. Provides frequent status reports and updates to manager.
• Independently solves a wide range of complex and diverse problems and evaluates and communicates short term impact of recommendations.
• Expands understanding and employs sensitivity in communications with culturally diverse audiences.
• Provides technical leadership, trains, mentors, and takes initiative to assist junior writers and others.
• Troubleshoots complex problems and engages others in problem-solving strategies to identify practical and effective solutions to complex issues.
• Evaluates the applicability and impact of technical writing methods and solutions referred by junior writers.
• Other duties as assigned

Required Qualifications

• Bachelor's Degree, or higher in English or Technical Writing
• Minimum 5 years of experience as a technical writer within an IVD/Medical Device Business (Life sciences)
• Experience working within a Quality Management System (QMS).
• Strong understanding of structured documentation and version control.
• Experience in medical device industry, regulations and governance requirements
• Advanced proficiency in MadCap Flare
• Strong written and verbal communication skills.

Preferred Qualifications

• Familiarity with global labeling requirements (FDA, EU MDR, IVDR, Health Canada, etc).
• Experience with Adobe Acrobat, Adobe FrameMaker, and graphics tools
• Knowledge of Smartsheet

Core Competencies

• Detail-oriented with strong quality focus
• Ability to manage multiple concurrent projects
• Strong cross-functional collaboration skills
• Regulatory awareness and risk-based thinking
• Process-oriented mindset
• Ability to work independently with minimal supervision

Key skills/competency

• Senior Technical Writer
• Medical Devices
• FDA Regulations
• ISO Standards
• MadCap Flare
• Quality Management System
• Structured Content
• Technical Documentation
• Regulatory Compliance
• Life Sciences