Technical Writer II
Heredia, CR
Additional Locations: Costa Rica-Heredia
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.
Hybrid Roles:
Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview.
About the role:
The Technical Writer II is responsible for creating, revising, and maintaining technical documentation that meets Boston Scientific Quality System and global regulatory standards. This position focuses on developing clear, concise, and accurate design history file (DHF), risk management, and post-market surveillance documentation for interventional cardiology medical devices, ensuring that the documentation is accessible to various internal and external stakeholders.
Your Responsibilities Include:
- Documentation Creation and Maintenance: Develop and maintain design history files (DHF), risk management file deliverables (e.g., Hazard Analysis, DFMEA), and other technical documents for interventional cardiology medical devices.
- Quality System and Regulatory Compliance: Help ensure that all documentation complies with:
- Relevant Boston Scientific Quality System requirements and good documentation practices (GDP).
- Relevant regulatory standards (e.g., FDA, ISO), and other global medical device regulations (e.g., MDR).
- Content Management: Manage the release and revision of version-controlled documents in the BSC document management system.
- Collaboration: Work closely with cross-functional teams including Regulatory Affairs, Research & Development, and Clinical Risk to gather information and ensure accuracy of technical content.
- Editing and Proofreading: Review and edit documentation for clarity, grammar, and style, ensuring consistency across all materials. Incorporate feedback from stakeholders to continuously improve documentation quality and usability.
What we're looking for:
- Education: Bachelor's degree in Technical Writing, English, Communications, Engineering, or a related field.
- Experience: Minimum of 2 years of experience in technical writing, preferably in the medical device industry.
- Language: Must be bilingual in Spanish and English with a strong command of the English language.
- Skills:
- Excellent writing, editing, and proofreading skills.
- Ability to manage multiple projects and meet deadlines.
- Proficiency in document management systems and content creation tools.
- Strong interpersonal and communication skills.
- Attention to detail and a commitment to producing high-quality documentation.
Preferred Qualifications:
- Previous experience working in a regulated environment.
- Working knowledge of medical device regulations and standards.
- Knowledge of medical terminology and clinical practices.
Requisition ID: 605389
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
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Technical Writer, Medical Device, Regulatory Affairs, Compliance, Law, Technology, Healthcare, Legal