Senior Technical Writer

Overview

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.

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 role involves working within FDA- and ISO-regulated environments and requires proficiency in Mad Cap Flare for structured, reusable content development.

• Perform large or complex portions of documentation projects across multiple product lines or specialization areas.
• Work on technically complex and high-impact projects and deliverables where ingenuity and basic business understanding is required.
• Create, revise, and seek approval of documentation and ensure consistency across documentation.
• Contribute to continuous improvement of templates, style guides, and publishing workflows.
• Contribute to the project strategy to meet target goals and milestones, evaluate resource allocation needs, and monitor project risks to determine the best mitigation path.
• Research issues outside current technical writing knowledge and select the most efficient methods or techniques to achieve objectives.
• Identify technical writing and medical device industry standards, processes, policies, practices, and tools, including SOPs, industry best practices, style guides, templates, desktop publishing tools, and applicable regulations (FDA, CE Marking, ISO).
• Apply knowledge to a variety of assignments reflecting proficiency in a broad range of complex topics.
• Translate specialized product needs, customer needs, operational policies and processes, and product use into feasible documentation requirements and recommendations.
• Research and analyze data relating to the development and distribution of technical documentation.
• Demonstrate advanced project management skills, systems knowledge, and basic business understanding.
• Coordinate work primarily across project teams, related groups, or within the department.
• Communicate proactively and effectively at all levels.
• Provide frequent status reports and updates to manager.
• Independently solve a wide range of complex and diverse problems and evaluate and communicate short-term impact of recommendations.
• Expand understanding and employ sensitivity in communications with culturally diverse audiences.
• Provide technical leadership, train and mentor junior writers, and take initiative to assist other staff.
• Troubleshoot complex problems and engage others in problem-solving strategies to identify practical and effective solutions.
• Evaluate the applicability and impact of technical writing methods and solutions referred by junior writers.

• Bachelor's Degree in English or Technical Writing (or higher).
• 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 Mad Cap Flare.
• Strong written and verbal communication skills.

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

• 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.

Haemonetics is an equal opportunity employer. We are committed to providing a diverse working environment and offer opportunities to all. All employment decisions are based on merit and aligned with the EEO legal requirements.

The base pay offered to the successful candidate will take into account location, education, job knowledge, skills, and experience. Incentives may also be provided as part of the compensation package. For non-sales roles, a discretionary annual bonus may be offered. Employees may be eligible for a discretionary long-term incentive plan. The base salary range for this role is $90100.00 to $153300.00 per annum.

Haemonetics offers a competitive suite of benefits including a 401k with up to 6% employer match and no vesting period, an employee stock purchase plan, flexible time off, vacation accrual, paid sick time, paid or floating holidays, parental leave, short- and…