Engineering Technical Writer

Summary:
Create, update, and manage technical documentation for medical device products in a regulated environment.

Job Requirements:

• Bachelor’s Degree and 2+ years of experience
• Experience in creating documentation changes in a regulated environment (Medical Device)
• Experience writing and updating Instructions for Use (IFU) and manual content to address quality-related issues
• Experience conducting cross-functional reviews of labeling changes
• Knowledge of FDA, EU MDR, and ISO standards

Preferred Skills:

• Experience with quality assurance standards in the medical device industry
• Familiarity with regulatory requirements for labeling and documentation

Job Responsibilities:

• Produce customer-facing product documentation including user guides, service manuals, and IFUs
• Support both clinician and patient labeling for medical device products
• Collaborate on R&D projects for new product development and maintenance of existing products
• Ensure documentation meets quality and regulatory standards
• Manage supporting documentation such as design plans, input requirements, and verification reports
• Investigate, document, and resolve labeling-related quality issues

Pay Details: $35.00 to $40.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance