Job Details
Posted 24 June, 2026
Job Id: 628840
Engineering – Sr Technical Writer
Job Description
As a Senior Technical Writer, you will support the development of customer-facing product labeling for an ablation product line. The labeling may include: instructions for use (IFU), manuals, user guides, device labels, and package labels. You may also work on marketing materials and medical literature. In addition to the labeling itself, you will be accountable for labeling supporting documentation, which may include design plans, requirements documents, review reports, and verification reports. You will directly support R&D projects for both new product development and released product maintenance.
We are seeking a highly independent, self-driven, and accountable technical writer with prior experience with medical device labeling and the regulatory process, who requires minimal supervision.
Key responsibilities include the following:
- Set the strategy and develop plans for projects impacting the labeling for this product line.
- Collaborate with departmental and cross-functional stakeholders and subject matter experts to develop the labeling content and resolve issues as they arise during the development process.
- Ensure compliance of labeling with all applicable regulatory (e.g., FDA, EU MDR, ISO standards, etc.) and quality requirements.
- Write and produce documentation that conforms to quality management system requirements.
- Produce and/or edit graphics, illustrations, and charts that are included within the labeling materials.
- Communicate project status and risks to program, functional, and business leaders.
- Provide input to project schedule development.
- Effectively manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met.
Required knowledge and experience:
- Advanced knowledge of the job area (breadth and depth), typically through advanced education plus experience.
- May have practical project management knowledge.
- Education/experience requirement: Baccalaureate degree (or qualifying foreign equivalent under 8 C.F.R. § 214.2(h)(4)(iii)(A)) and a minimum of 4 years relevant experience, or an advanced degree with a minimum of 2 years relevant experience.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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