Technical Writer - Sterling Engineering, Inc.
San Jose, CA 95134
About the Job
Title: Technical Writer
Location: San Jose, California
Location: San Jose, California
Hire Type: Contract-to-Hire
Target Pay Range: $45.00 - $50.00/hour (W2, with full employee benefits)
Overview:
Sterling has helped build careers for thousands of professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterling provides exciting work with exceptional employers across the U.S.
As a contract employee of Sterling, you are eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.
Job Summary:
The Technical Writer will be responsible for creating and managing documentation for the Research and Development department of a medical device company. 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.
Job 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 communicates updates to customers.
- Follows Good Document practices (GDP) for all documentation created/reviewed and stays current on all required training.
Qualifications:
- Bachelor’s Degree or Master’s in Engineering, Science, or a related field.
- 3+ 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 Quality Management System, 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.
- Ability to work collaboratively in a cross-functional team environment.
- Ability to prioritize and manage multiple projects simultaneously.
- Ability to work onsite in San Jose, CA.
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identify, national origin, disability, protected veteran status, or genetic information.
Source : Sterling Engineering, Inc.
