📌 Core Information
🔹 Job Title: Staff Technical Writer
🔹 Company: Cepheid
🔹 Location: Sunnyvale, California, United States
🔹 Job Type: Full-Time, On-Site
🔹 Category: Biotechnology Research
🔹 Date Posted: April 8, 2025
🔹 Experience Level: 10+ years
🔹 Remote Status: On-site
🚀 Job Overview
Key aspects of this role include:
- Managing product labeling for Cepheid’s Xpert tests and GeneXpert instrument systems
- Collaborating with cross-functional teams to create, edit, format, and publish regulatory-compliant documents
- Leading and managing functional teams and projects to solve complex problems
- Driving quality and consistency in documentation
- Coordinating translation requests and managing the release of final documentation
ASSUMPTION: This role requires a high level of attention to detail, strong organizational skills, and the ability to work effectively with cross-functional teams.
📋 Key Responsibilities
✅ Manage the publication and translation of product labeling for Cepheid’s Xpert tests and GeneXpert instrument systems
✅ Collaborate with cross-functional teams (e.g., Product Transfer, R&D, Hardware/Software Engineers, Clinical) to create, edit, format, and publish primary labeling
✅ Lead and manage functional teams and projects to solve complex problems and identify innovative solutions
✅ Drive quality and consistency by reviewing and peer-reviewing publications for content accuracy, format, and adherence to Cepheid’s style guide
✅ Coordinate translation requests with external suppliers, format post-translation documents, and manage the release of final documentation in Cepheid’s system
ASSUMPTION: This role involves working with sensitive and confidential information, requiring a high level of discretion and professionalism.
🎯 Required Qualifications
Education: Bachelor’s degree in Life Sciences with 8+ years of technical writing experience in the biotech industry or Master’s degree with 6+ years of related work experience
Experience: 10+ years of technical writing experience in the biotech industry, with a focus on medical equipment and regulatory compliance
Required Skills:
- Proficiency in XML/DITA CCMS, Adobe FrameMaker, Acrobat, Illustrator, Photoshop, InDesign, Microsoft Word, and ABBYY FineReader
- Strong command of English grammar, punctuation, and writing, with attention to detail, accuracy, and adherence to policies, procedures, and style guides
- Experience participating in product development teams, creating and updating SOPs, and conducting verification and validation of technical publications
- Excellent organizational and communication skills with the ability to prioritize, multi-task, and work with focused urgency as required by project timelines
Preferred Skills:
- Proficiency in preparing images for technical documentation and experience as a CMS Administrator
- Experience in medical equipment writing and familiarity with Agile documentation systems
ASSUMPTION: While not explicitly stated, proficiency in French, Spanish, or other languages commonly used in international medical documentation would be beneficial for this role.
💰 Compensation & Benefits
Salary Range: $130,400 - $165,000 per year
Benefits:
- Medical/Dental/Vision Insurance
- Paid Time Off
- 401(k)
Working Hours: Full-time, typically Monday through Friday, 8:00 AM to 5:00 PM, with flexibility as needed
ASSUMPTION: The salary range provided is an estimate based on industry standards for similar roles in the biotechnology sector. Actual compensation may vary based on factors such as experience, skills, and performance.
📌 Applicant Insights
🔍 Company Context
Industry: Biotechnology Research – Cepheid specializes in molecular diagnostics, focusing on infectious diseases, cancer, and genetic testing. They are a leading provider of fast, accurate, and flexible diagnostic solutions.
Company Size: 5,001-10,000 employees – Cepheid is a subsidiary of Danaher Corporation, a global science and technology innovator committed to helping its customers solve complex challenges across a broad range of industries.
Founded: 1996 – Cepheid was founded with a mission to improve healthcare through pioneering molecular diagnostics that combine speed, accuracy, and flexibility.
Company Description:
- Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility
- The company’s GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures
- Cepheid’s broad test portfolio spans respiratory infections, blood virology, women’s and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology, and human genetics
Company Specialties:
- Molecular Diagnostics
- Genetic Testing
- Molecular Biology
- Infectious Diseases
- Cancer
- PCR
Company Website: www.cepheid.com
ASSUMPTION: Cepheid’s focus on molecular diagnostics and commitment to improving healthcare make it an attractive employer for individuals passionate about innovative technology and its real-life impact.
📊 Role Analysis
Career Level: Experienced Professional – This role requires a high level of expertise in technical writing, with a focus on medical equipment and regulatory compliance.
Reporting Structure: The Staff Technical Writer will report directly to the Manager of Technical Publications within Cepheid’s Regulatory Affairs – New Product Development group.
Work Arrangement: On-site, full-time position located in Sunnyvale, CA, with flexibility for remote work as needed.
Growth Opportunities:
- Potential advancement to Senior Technical Writer or Team Lead roles
- Expansion of responsibilities to include mentoring and training of junior team members
- Opportunities to work on high-impact projects and collaborate with cross-functional teams
ASSUMPTION: Cepheid’s commitment to professional development and growth opportunities makes it an attractive employer for individuals seeking to advance their careers in technical writing.
🌍 Location & Work Environment
Office Type: On-site, corporate office environment
Office Location(s): 904 Caribbean Drive, Sunnyvale, CA 94089, US
Geographic Context:
- Sunnyvale, CA is located in the heart of Silicon Valley, offering a vibrant tech industry and diverse cultural scene
- The area is known for its mild Mediterranean climate, with warm, dry summers and cool, wet winters
- Sunnyvale is home to numerous Fortune 500 companies and offers excellent opportunities for professional growth and development
Work Schedule: Full-time, typically Monday through Friday, 8:00 AM to 5:00 PM, with flexibility as needed
ASSUMPTION: Cepheid’s on-site work arrangement provides an opportunity to collaborate closely with cross-functional teams and build strong working relationships with colleagues.
💼 Interview & Application Insights
Typical Process:
- Online application submission
- Phone or video screen with the Hiring Manager
- On-site or virtual interview with the Hiring Manager and cross-functional team members
- Final interview with the Director of Technical Publications
- Background check and offer extension
Key Assessment Areas:
- Technical writing skills and experience with medical equipment and regulatory compliance
- Ability to work effectively with cross-functional teams and manage complex projects
- Attention to detail, accuracy, and adherence to policies, procedures, and style guides
- Cultural fit with Cepheid’s values and work environment
Application Tips:
- Tailor your resume to highlight your technical writing experience, particularly with medical equipment and regulatory compliance
- Prepare a cover letter that demonstrates your passion for Cepheid’s mission and your qualifications for the role
- Be ready to provide samples of your technical writing work, showcasing your ability to create clear, accurate, and regulatory-compliant documents
- Research Cepheid’s company culture and be prepared to discuss how your values and work style align with the organization
ATS Keywords: Technical Writing, Medical Equipment, Regulatory Compliance, XML, DITA, Adobe FrameMaker, Acrobat, Illustrator, Photoshop, InDesign, Microsoft Word, ABBYY FineReader, Attention to Detail, Organizational Skills, Communication Skills, SOPs, Verification, Validation
ASSUMPTION: Cepheid’s ATS system may prioritize candidates who include these keywords in their resume and application materials.
🛠️ Tools & Technologies
- XML/DITA CCMS
- Adobe FrameMaker
- Acrobat
- Illustrator
- Photoshop
- InDesign
- Microsoft Word
- ABBYY FineReader
ASSUMPTION: Proficiency in these tools is essential for success in this role, as they are used daily to create, edit, format, and publish technical documentation.
👔 Cultural Fit Considerations
Company Values:
- Innovation – Cepheid is committed to pioneering molecular diagnostics that combine speed, accuracy, and flexibility
- Quality – The company is dedicated to delivering high-quality, reliable, and accurate diagnostic solutions
- Collaboration – Cepheid fosters a culture of teamwork and cross-functional collaboration to drive success
Work Style:
- On-site, full-time position with flexibility for remote work as needed
- Fast-paced, dynamic work environment with a focus on meeting project timelines and deadlines
- Opportunities for professional growth and development within a large, global organization
Self-Assessment Questions:
- Do you have a strong command of English grammar, punctuation, and writing, with attention to detail, accuracy, and adherence to policies, procedures, and style guides?
- Are you comfortable working in a fast-paced, dynamic work environment with a focus on meeting project timelines and deadlines?
- Do you thrive in a collaborative, cross-functional work environment and enjoy partnering with diverse teams to achieve common goals?
ASSUMPTION: Cepheid’s cultural fit considerations prioritize candidates who demonstrate strong technical writing skills, attention to detail, and a collaborative work style.
⚠️ Potential Challenges
- The role requires managing complex projects and working with tight deadlines, which can be stressful at times
- Cepheid’s fast-paced work environment may not be suitable for individuals who prefer a slower-paced, more predictable work setting
- The role involves working with sensitive and confidential information, requiring a high level of discretion and professionalism
- The on-site work arrangement may not be suitable for individuals who prefer a remote or hybrid work arrangement
ASSUMPTION: These potential challenges should be carefully considered by candidates to ensure they are a good fit for the role and Cepheid’s work environment.
📈 Similar Roles Comparison
- Staff Technical Writer vs. Senior Technical Writer – The Staff Technical Writer role focuses on managing the publication and translation of product labeling, while the Senior Technical Writer role may involve additional responsibilities such as mentoring and training junior team members and leading projects
- Medical Equipment Writing vs. Pharmaceutical Writing – Medical equipment writing focuses on creating clear, accurate, and regulatory-compliant documentation for medical devices, while pharmaceutical writing focuses on creating documentation for pharmaceutical products, such as drugs and biologics
- Cepheid vs. Competitor Companies – Cepheid is a leading provider of molecular diagnostics, with a strong focus on innovation, quality, and collaboration. Competitor companies may offer similar roles but may have different company cultures, work environments, and growth opportunities
ASSUMPTION: Candidates should carefully consider the differences between these roles and companies to ensure they are a good fit for their career goals and personal preferences.
📝 Sample Projects
- Creating clear, accurate, and regulatory-compliant Instructions for Use (IFUs) for Cepheid’s Xpert tests
- Managing the end-to-end creation of operator’s manuals, user guides, getting started guides, and service manuals for Cepheid’s instrument systems
- Driving quality and consistency by reviewing and peer-reviewing publications for content accuracy, format, and adherence to Cepheid’s style guide
ASSUMPTION: These sample projects provide insight into the day-to-day responsibilities and tasks associated with the Staff Technical Writer role at Cepheid.
❓ Key Questions to Ask During Interview
- Can you describe the typical project timeline for creating and publishing regulatory-compliant documents for Cepheid’s Xpert tests and GeneXpert instrument systems?
- How does the Technical Publications team collaborate with cross-functional teams, such as Product Transfer, R&D, Hardware/Software Engineers, and Clinical, to create, edit, format, and publish primary labeling?
- What opportunities are there for professional growth and development within the Technical Publications team and Cepheid as a whole?
- How does Cepheid support work-life balance for its employees, particularly for those in full-time, on-site roles?
- What are the most challenging aspects of the Staff Technical Writer role, and how can I best prepare to succeed in this position?
ASSUMPTION: These key questions help candidates better understand the role, the work environment, and the company culture, allowing them to make an informed decision about their fit for the position.
📌 Next Steps for Applicants
To apply for this position:
- Submit your application through this link
- Tailor your resume to highlight your technical writing experience, particularly with medical equipment and regulatory compliance
- Prepare a cover letter that demonstrates your passion for Cepheid’s mission and your qualifications for the role
- Be ready to provide samples of your technical writing work, showcasing your ability to create clear, accurate, and regulatory-compliant documents
- Follow up with the Hiring Manager one week after submitting your application to inquire about the status of your application
⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.
