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 II on the WATCHMAN team, 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 across new product development and sustaining projects.
Your responsibilities will include :
- Co-author or contribute to the creation and revision of engineering deliverables
- Plan documents and create the draft of documents for the engineer or team
- Interface cross-functionally within the product development team to acquire source material for documents and to develop understanding of the products and processes
- Apply corporate and regulatory documentation requirements
- Clearly and correctly state and summarize technical information and conclusions in documents
- Make suggestions or corrections to make a document clearer and more concise
- Initiate document Change Notices. Act as an SME for the document management system
- Aid the team in preparing for and documenting major milestone reviews
- Manage the project records during development.
- Develop and maintain design history files, risk management file deliverables (e.g., Hazard Analysis, DFMEA), post-market surveillance deliverables, and other technical documents
Required qualifications :
Education : Bachelor's degree in Technical Writing, English, Communications, Engineering, or a related field.Experience : Minimum 2 years' experience working in a regulated industryExperience working with Microsoft Word, Microsoft Excel, and PowerPointPreferred qualifications :
Exposure to or experience with Windchill or other documentation control systemsExposure to Medical Device industryStrong writing, editing, and communication skillsAbility to work in collaboration with others on a project team and independently on tasksAptitude to understand engineering and other technical informationProject management and time management skillsProblem solving skills and an ability to respond and adapt to changeBoston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
J-18808-Ljbffr