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, study protocols, study reports, verification and validation reports, instruction for use and user manuals.
· Coordinates change requests within change management process for R&D (change in specifications, labeling, SOP)
· Reviews and audits other technical publications deliverables and consistently delivers quality documentation.
· As regulations change and quality systems are merged/aligned, execute the creation/refinement of documentation.
· Creates end-user regulatory complaint product labeling.
· Contributes to new product development and design change activities in the areas of labeling design/release, technical writing, development of artwork/images and development.
· Collaborates with cross-functional teams to gather information and ensure documentation is accurate, complete, and consistent.
· Manages the review and approval process for all technical documentation to ensure compliance with regulatory requirements.
· Ensures documentation is up-to date, accurate and accessible to all stakeholders.
· Assists in development and implementation of documentation standards, policies and procedures.
· Provides weekly summary of activities, creates project plans for tasks assigned, prioritizes, and effectively communicate updates to customers.
· Follows Good Document practices (GDP) for all documentation created/reviewed and staying current on all required training.
Knowledge, Experience, Skills:
· Bachelor's degree or Master's in engineering, Science, 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.
Type of Role: Contract to Hire
Shift / Hours: Full Time Onsite, can be hybrid 2 days a week after full training/manager approval
M-F - 8-5 pm
Location: San Jose, CA
Hourly Range: $45-$50/hr.
Apply now and one of our recruiters will reach out to you!
Balance Staffing is proud to be an equal-opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, Veteran status, or any other characteristic protected by federal or state law.
