Lead Technical Writer

About

Join our dynamic team at Haemonetics, where we are on the lookout for dedicated talent. If you are seeking a challenging yet rewarding career in a diverse and vibrant work environment, this is the place for you!

The Lead Technical Writer will play a crucial role in creating, revising, and maintaining comprehensive end-user documentation for medical devices, ensuring adherence to all regulatory and quality system requirements. The ideal candidate will possess extensive experience in FDA- and ISO-regulated environments and be highly skilled in using MadCap Flare for developing structured, reusable content. This role requires a balance of independence and collaborative effort to guarantee documentation accuracy, regulatory compliance, and uniformity across various product lines.

Responsibilities

As a Lead Technical Writer, you will have the opportunity to:

• Oversee large or intricate documentation projects across multiple product lines or areas of specialization.
• Engage in technically sophisticated and high-impact projects, exercising creativity and an understanding of business principles.
• Draft, update, and obtain approvals for technical documents while ensuring consistency throughout.
• Participate in the enhancement of templates, style guides, and publishing workflows to improve efficiency.
• Contribute to project strategies, managing resources effectively, and assessing potential risks for optimal mitigation.
• Conduct independent research to address topics beyond existing technical writing expertise, applying effective methods to achieve goals.
• Recognize and apply medical device industry standards, processes, policies, and regulations, including relevant Standard Operating Procedures (SOPs).
• Exhibit advanced knowledge of technical writing techniques and theories, translating complex product and customer needs into clear documentation requirements.
• Analyze data to inform the development and dissemination of technical documentation.
• Demonstrate exceptional project management capabilities along with proficient systems knowledge and basic business insight.
• Coordinate work across project teams and related departments.
• Communicate effectively at all levels, providing regular updates and status reports to management.
• Employ problem-solving skills to tackle complex issues while assessing the short-term implications of various recommendations.
• Enhance cultural awareness in communication with diverse audiences.
• Provide mentorship and technical leadership to junior writers and team members.
• Resolve complex issues by engaging in collaborative problem-solving strategies.
• Evaluate the techniques and solutions suggested by junior writers to ensure quality documentation.
• Undertake additional responsibilities as assigned to meet business needs.

Qualifications

Required Qualifications:

• Bachelor's Degree or higher in English or Technical Writing.
• At least 5 years of experience as a technical writer within the IVD/Medical Device sector (Life Sciences).
• Experience working within a Quality Management System (QMS).
• Strong understanding of structured documentation and version control.
• Knowledge of medical device industry regulations and governance.
• Advanced proficiency in MadCap Flare.
• Exceptional written and verbal communication abilities.

Preferred Qualifications:

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

Core Competencies

• Detail-focused with a strong commitment to quality.
• Ability to manage multiple projects simultaneously.
• Strong collaborative skills across functions.
• Awareness of regulatory standards and risk-based thinking.
• Process-oriented with a results-driven mindset.
• Able to work independently with minimum supervision.

About Haemonetics

Haemonetics is an equal opportunity employer. Join us and be a part of a team dedicated to improving lives through innovation and quality in the medical device industry.

Salary Information

The base salary range for this role is: $90,100.00-$153,300.00/Annual.