Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:

The Technical Writer will play a crucial role in supporting the development and release of cutting-edge medical device software. This position involves collaborating closely with development, product, and regulatory teams to produce clear, accurate, and compliant documentation. From defining features for the development team to creating engaging release notes and regulatory materials, the Technical Writer ensures that all written content supports both internal and external audiences effectively and adheres to medical device industry standards.

Feature Definition and Development Support:

Collaborate with product managers, clinicians, business analysts, and developers to refine feature definitions and ensure alignment with user and business needs.

Translate technical and clinical specifications into user-friendly descriptions to guide the development team.

Document workflows, diagrams, and use cases to clarify complex processes for stakeholders.

Release Communication:

Produce clear, concise release notes to communicate new features, enhancements, and bug fixes to end-users and stakeholders.

Create engaging and informative release videos that demonstrate new features and their functionality.

Ensure consistency and accuracy in all release-related communications, aligning with brand and regulatory guidelines.

Regulatory Documentation:

Develop and maintain labeling, user manuals, and clinical guides in compliance with medical device industry standards (e.g., IEC 62304, FDA, MDR).

Work closely with the regulatory team to ensure all documentation meets submission requirements for global markets.

Maintain version control and ensure traceability of documentation to software requirements.

Collaboration and Communication:

Act as a liaison between technical teams and non-technical stakeholders to ensure mutual understanding of documentation requirements.

Facilitate feedback sessions with users, clinicians, and other stakeholders to improve documentation usability.

Support the development and maintenance of a style guide to standardize content across the organization.

Continuous Improvement:

Use user feedback and usability testing to refine and improve documentation quality and accessibility.

Stay up to date on medical device documentation best practices and industry standards.

Explore new tools and techniques to streamline the documentation process and enhance its impact.

What you’ll need (Required):

Bachelor's Degree in related field, 3 years’ experience technical writing is required and
biotechnology industry experience is preferred

What else we look for (Preferred):

Exceptional writing, editing, and organizational skills.

Proficiency with documentation tools such as Adobe FrameMaker, MadCap Flare, or Microsoft Word.

Familiarity with Agile development environments and tools like Azure DevOps.

Basic understanding of software development processes and the ability to read and interpret technical documents.

Experience producing multimedia content, including instructional videos and graphics.

Experience creating and maintaining traceable documentation in compliance with industry standards.

Familiarity with UX principles and the ability to collaborate with design teams to create user-friendly content.

Strong interpersonal skills to work effectively across multidisciplinary teams

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For Illinois, the base pay range for this position is $66,000 to $94,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.