BD (Becton, Dickinson and Company) Senior Technical Writer-Editor in San Diego, California
Job Description Summary
In this position, you will add value to BD by writing and editing engineering documentation being submitted for government regulatory review, so that they enhance our products’ safety, usability, compliance, design intent, and ultimately our customers’ experience.
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
About the role:
As Senior Technical Writer-Editor you will add value to BD by writing and editing engineering documentation being submitted for government regulatory review, so that they enhance our products’ safety, usability, compliance, design intent, and ultimately our customers’ experience.
Reviews and edits quality and engineering documentation submitted to the U.S. Food and Drug Administration (FDA) for 510(k) applications along with other country regulatory bodies to ensure clarity, consistency, accuracy, and adherence to writing standards that meets expectations of high-quality regulatory documentation.
Facilitates the development of technical documentation into clinical documentation and finally customer-facing documentation. For example, translating product test data into usable information for the end user.
Reviews and corrects any grammatical, punctuation, and spelling errors in quality documentation such as test protocols and test reports.
Creates illustrations, flow charts, diagrams, line art, in addition to product photos for both quality and technical documentation.
Provides recommendations to engineers on optimizing engineering data expressed in graphs, illustrations, and tables to ensure clarity and consistency.
Participates in various product workstream teams, for example, product safety assurance efforts for streamlining product safety protocols.
Collaborates with subject matter authorities in the review and development of instructions-for-use (IFU) design specifications as part of the product’s quality documentation.
Reviews product data, requirements, specifications, drawings, part lists, and prototypes to develop customer-facing and internal-facing documentation.
Collaborates with quality, regulatory, clinical, marketing managers, engineers, and other subject matter authorities to determine type of content and level of detail to be used in product labeling especially IFU and to suggest changes to enhance a document's readability, clarity, conciseness, and style.
Communicates effectively with all levels of management, business units (corporate and international), and possesses a high degree of flexibility/selectivity in prioritizing business unit results to meet company goals.
Adheres to established templates and guidelines for developing product labeling (documentation).
Manages the labeling review process and prepares documents for final production and release.
Documents suites of BD products, including hardware and software user guides, installation guides, communication/service bulletins, service manuals, tip sheets, product and device labels, and application help.
Participates as required in training on regulatory issues affecting own area of work.
Education and experience required:
Bachelor's degree in English, Journalism, Communications, or other liberal arts degree.
Experience working in a regulated industry such as pharmaceuticals or medical devices.
Extensive experience with regulatory compliance processes. Strong background in supporting regulatory requirements to ensure adherence to regulatory guidelines.
Demonstrated ability to be highly collaborative with marketing, clinical, quality, and regulatory reviewers.
To be successful in this role, you require…
Five or more years writing and editing hardware/software user guides (print and online) and other technical product documentation.
Ability to effectively manage the delivery of prioritized tasks.
Ability to demonstrate a high level of initiative to gather information for developing documentation.
Ability to work independently with minimal supervision.
Effective at thinking independently and solving problems with product core team members.
Ability to work under compressed deadlines and must be able to deal with unresolved situations, frequent project changes, delays, or other events.
Ability to handle multiple projects with excellent follow-up and project management skills.
Familiarity with electro-mechanical concepts and software application usage.
Experience in device labeling and/or packaging content development is a plus.
Familiarity with large company engineering change control processes and Agile software development methodologies.
Experience with Microsoft-based applications (Microsoft Office 365™)
Expert level experience with Microsoft™ Word™
Minimum of two years' experience writing for online help
Experience with SAP, Oracle, or similar enterprise resource planning (ERP) system.
Experience in version control systems (VCS) such as, Perforce, Apache™ Subversion™, Microsoft™ Team Foundation Server, or GitHub.
Knowledge of photography and photo editing software such as Adobe™ Photoshop™.
Skilled in both electronic and hard copy markup (Acrobat, tracked changes in Microsoft™ Word™, standard editorial and proofreading symbols).
Knowledge and experience with desktop publishing (DTP) software applications (MadCap™ Flare, Adobe™ FrameMaker™, Adobe™ InDesign™, Adobe™ Illustrator™) as applicable for technical documentation.
Click on Apply if this sounds like you!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Primary Work Location
USA CA - San Diego TC Bldg C&D
US BD 1st Shift 8am-5pm (United States of America)