Boston Scientific Design Quality Technical Writer 

United States, Minnesota 

138466644

About the role:

Technical writers at Boston Scientific play a crucial role in ensuring that product documentation is complete, accurate, and compliant with internal quality system requirements, government regulations, and international quality standards.

As a Design Quality Technical Writer I in the Interventional Cardiology division, you will work closely with Design Quality Engineering and other cross-functional roles to develop and maintain Design History Files, Risk Management Files, and other technical documentation for complex interventional cardiology devices.

Most importantly, you will join a dynamic team dedicated to advancing interventional cardiology technology and improving the lives of patients every day.

Your responsibilities will include:

• Documentation Creation and Maintenance: Develop and maintain design history files, risk management file deliverables (e.g., Hazard Analysis, DFMEA), post-market surveillance deliverables, 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.

  • 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.

Required qualifications:

• Bachelor’s degree in Technical Writing, English, Communications, Engineering, or a related field

• Excellent writing, editing, and proofreading skills

Preferred qualifications:

• Internship, academic project, or coursework experience related to Technical Writing

• Experience working in a regulated industry

• Ability to manage multiple projects and meet deadlines

• Proficiency in document management systems, such as Windchill, and content creation tools

• Strong interpersonal and communication skills

• Attention to detail and commitment to producing high-quality documentation

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.