Sr Technical Writer
Location: San Jose, CA, United States
Position Type: Unfixed Term
Job Function: Other
A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.
Description
The Company
Specific Diagnostics, a BioMérieux company, is a medical device company that has developed a rapid antimicrobial susceptibility test (AST) system that delivers phenotypic AST directly from positive blood cultures. Our mission is to provide innovative and reliable medical devices that improve patient outcomes and enhance the life of people around the world. Our team of highly skilled professionals is dedicated to excellence in research, development and manufacturing and we are looking for a Technical Writer jo Join our Research and development department.
Job Overview
The Sr. technical Writer will be responsible for creating and managing documentation for the Research and Development department. This position requires a thorough understanding of medical device development processes, documentation requirements and regulatory compliance. The technical Writer will work closely with cross-functional teams, including Engineers, Scientists, Regulatory Affairs and Quality Assurance, to ensure accurate and timely documentation is produced.
PRIMARY DUTIES
- Develop and maintain technical documentation that meets organizational standards, including but not limited to, standard operating procedures, procedures, design specifications, test protocols, verification and validation reports, instruction for use and user manuals.
- Collaborate with cross-functional teams to gather information and ensure documentation is accurate, complete, and consistent.
- Manage the review and approval process for all technical documentation to ensure compliance with regulatory requirements.
- Ensure documentation is up-to date, accurate and accessible to all stakeholders.
- Assist in development and implementation of documentation standards, policies and procedures.
KNOWLEDGE, EXPERIENCE & SKILLS
- Bachelor's degree or Master's in engineering, Science, Technical Writing, or a related field.
- 3-5 years of experience in technical writing for medical device development of complex systems including hardware, software, and reagents.
- Experience working in a regulated industry such as FDA or ISO.
- Experience with electronic document management software (Livelink or similar) for tracking and processing document change requests.
- Experience with Quality Management System.
- Experience with Product Development and Design Control Processes.
- Proficient in documentation tools such as Office, Adobe Acrobat and content management systems.
- Excellent written and verbal communication skills with the ability to effectively communicate technical information to a variety of audiences.
- Strong attention to detail and accuracy.
- Ability to work collaboratively in a cross-functional team environment.
- Ability to prioritize and manage multiple projects simultaneously.
If you are interested in this opportunity, please submit your resume and a cover letter for consideration. We look forward to hearing from you.
Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].
BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
