Job Title: Technical Writer -Medical Device
Duration: 12+ Months (Possible extension)
Location: Valencia, CA 91355
100% Remote Role
Responsibilities:
- The Technical Writer role sits within Design Assurance and requires candidates to come from a regulated industry environment, with a strong preference for medical devices, life sciences, or pharmaceutical backgrounds.
- Responsibilities will include managing document change actions (DCAs), organizing and synthesizing technical inputs into clear documentation, and performing data mapping and cross-referencing across multiple Excel datasets.
- Experience supporting product development teams by drafting, revising, and consolidating technical documentation such as IFUs, SOPs, and work instructions, using source data provided by engineering teams.
- Strong understanding of quality design assurance concepts and experience working with engineering documentation, including hazard analysis, design validation, usability, and complaint review.
- Candidates should have hands-on experience creating or revising development and quality documentation (e.g., design and development plans, risk management files, validation protocols/reports, SOPs/WIs, and IFUs) and be able to clearly translate complex technical information into concise, well-structured documents.
- Design Assurance processes (DCAs/RCAs), with experience supporting or contributing to regulatory documentation.
- Familiarity with related quality activities such as DFMEA, CAPA, and test method validation is considered a plus
- Plan, organize, write, revise, summarize, edit, and proofread technical engineering documents and maintain project records.
- Write, revise, edit, and proofread assigned project documents.
- Author or contribute to the creation and revision of engineering project deliverables.
- Clearly and correctly state and summarize technical information and conclusions in documents.
- Manage, plan, organize, and communicate project information and project activities.
- Interface with external partners to plan, organize, review, edit, and finalize project documents.
- Organize and place raw data into tables, utilizing appropriate software tools.
- Plan documents and create the draft or framework of a document for the engineer or team.
- Participate in or lead department projects as assigned.
- Make suggestions or corrections in order to make a document more clear & concise.
Education/Experience:
- 10 - 14 Years with BA 8 - 12 Years with MBA