Pay Range: $60 to $65/Hour on W2

Job Description:
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.

**Day-to-day 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.

*The ideal candidate will have 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. They will have a 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.

*Additional strength includes exposure to 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.

Job Purpose
This tech writer will work as a team member on a product development project, bringing clarity and consistency to documents through accurate and concise writing and effective use of document format. In summary, this tech writer will plan, organize, write, revise, summarize, edit, and proofread technical engineering documents and maintain project records.

Key Responsibilities
1. Write, revise, edit, and proofread assigned project documents.
2. Author or contribute to the creation and revision of engineering project deliverables.
3. Clearly and correctly state and summarize technical information and conclusions in documents.
4. Manage, plan, organize, and communicate project information and project activities.
5. Interface with external partners to plan, organize, review, edit, and finalize project documents.
6. Organize and place raw data into tables, utilizing appropriate software tools.
7. Plan documents and create the draft or framework of a document for the engineer or team.
8. Participate in or lead department projects as assigned.
9. Interface cross-functionally within the product development team to acquire source material for documents and to develop understanding of the products and processes.
10. Make suggestions or corrections in order to make a document more clear and concise.
11. Manage documentation change requests in PDM.
12. Apply documentation requirements in accordance with corporate and regulatory standards.
13. Maintain appropriate training records in Learning Connect system.

Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications
10 – 14 Years with BA 8 – 12 Years with MBA