BD (Becton, Dickinson and Company) is hiring an Associate Director, Senior Technical Writer to provide strategic leadership for the technical documentation lifecycle of our Class II medical devices. In this role, you will build and lead a high-performing team while ensuring all customer-facing and internal technical content meets the highest standards of clarity, usability, and regulatory compliance.
What You'll Do
- Lead, develop, and mentor a team of technical writers, illustrators, and documentation specialists, providing coaching and career development.
- Build a high-performing documentation function by establishing clear goals, aligning with organizational priorities, and fostering a culture of quality and accountability.
- Oversee resource planning, workload balancing, and vendor or contractor management.
- Represent the documentation function in leadership forums and influence decisions affecting product development, quality, labeling, and regulatory deliverables.
- Own the end-to-end documentation lifecycle for content including user manuals, IFUs, installation guides, troubleshooting guides, and regulatory submission documents.
- Ensure compliance with FDA, EU MDR, ISO 13485, and other relevant standards by embedding requirements into documentation workflows.
- Establish, maintain, and enforce documentation standards, best practices, templates, and style guides across product lines.
- Drive documentation quality through editorial review and the improvement of content clarity, structure, and usability.
- Partner with engineering, quality assurance, regulatory affairs, clinical affairs, marketing, and customer support to gather information and validate content.
- Lead the creation and review of IFU design specifications and quality documentation, collaborating with subject matter experts.
- Serve as the documentation authority in cross-functional meetings, influencing project scope, timelines, and risk mitigation.
- Communicate effectively with senior-level stakeholders and international partners to ensure alignment and timely delivery.
- Create and edit technical documents with a high degree of accuracy, clarity, and regulatory compliance.
- Develop visual content including diagrams, illustrations, flow charts, and product photography; advise on data visualization.
- Stay current on industry trends, regulatory developments, and advancements in technical communication tools.
- Manage documentation schedules, dependencies, resource requirements, and deliverables within fast-paced project environments.
- Drive process improvements to increase efficiency, reduce cycle times, and enhance quality.
- Oversee version control, change management, and documentation integration within enterprise systems.
What We're Looking For
- Bachelor’s degree in Technical Communication, Engineering, or a related technical or communications field.
- 7+ years of experience in technical writing, technical communication, or documentation development.
- 5+ years of experience within a regulated industry (medical devices strongly preferred; pharma/biotech acceptable).
- 3+ years of people leadership experience, including managing writers, contractors, or cross-functional documentation teams.
- Extensive experience in regulated industries with deep knowledge of regulatory compliance and documentation requirements.
- Demonstrated leadership experience managing teams or cross-functional documentation programs.
- Strong collaboration skills working with engineering, marketing, clinical, quality, and regulatory teams.
- Proven ability to manage multiple complex projects under tight deadlines.
- Strong initiative, problem-solving skills, and ability to work independently with minimal supervision.
- Familiarity with electro-mechanical systems and software applications.
- Experience with device labeling and packaging content.
- Knowledge of engineering change control processes and Agile methodologies.
- Experience with ERP systems such as SAP or Oracle.
- Proficiency with version control systems (Perforce, Subversion, TFS, GitHub).
- Skilled in technical editing tools (Microsoft Word, Acrobat, editorial symbols).
- Proficiency with DTP tools (MadCap Flare, Adobe FrameMaker, InDesign, Illustrator, XML, DITA).
- Experience with photography and image editing (Adobe Photoshop).
Nice to Have
- Master’s degree in Technical Communication, Regulatory Science, Engineering, Biomedical Engineering, Life Sciences, or a related discipline.
- Prior leadership of technical writing teams within a medical device organization.
- Experience working with global regulatory submissions and country-specific documentation requirements.
Technical Stack
- Documentation: Microsoft Word, Acrobat, MadCap Flare, Adobe FrameMaker, InDesign, Illustrator, XML, DITA
- Graphics: Adobe Photoshop, Illustrator
- Version Control: Perforce, Subversion, TFS, GitHub
- Enterprise Systems: SAP, Oracle
Team & Environment
You will lead a team of technical writers, illustrators, and/or documentation specialists.
Work Mode
This is an onsite position located in San Diego, CA at BD's Bldg A&B.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
