Medical Device Engineer
Please Share resume to sagar.bhardwaj@diverselynx.com
Role: Medical Device Engineer
Location: Puerto Rico, TX (Onsite)
Job Description :
Validation, CSV, IQ, OQ ,PQ, FAT, SAT, Technical writer, documentation
Technical Writer & Validation Support Minimum of 3 Yr exp supporting the validation of a major capital automation projects Technical Writing Skills
- Writing and Editingo Strong writing, grammar, and editing abilities to create clear and concise documentation.
o Ability to adapt writing style to various audiences (e.g., end users, technical teams, or regulatory bodies).
- Document Design and Formatting
o Proficiency with documentation tools (e.g., Microsoft Word, Adobe FrameMaker, or Google Docs).o Knowledge of design principles to create well-structured documents (manuals, user guides, SOPs, etc.).
- Version Controlo Familiarity with tools like Git, SVN, or SharePoint to manage document revisions and updates.
- Understanding of Documentation Standards
o Familiarity with documentation standards such as DITA (Darwin Information Typing Architecture) or the S1000D standard.
o Ability to create and maintain templates, style guides, and consistency in documentation.
- Technical Communication Tools
o Experience with tools like Confluence, MadCap Flare, or HelpNDoc for creating and managing online help systems and documentation.
Validation Support Skills
- Validation Knowledge
o Understanding of validation processes, especially in regulated industries (e.g., healthcare, pharmaceuticals, or software validation).
o Knowledge of validation protocols like IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
- Quality Management Systems (QMS)o Familiarity with industry standards like ISO 9001, FDA regulations (21 CFR Part 11), and GxP (Good Laboratory Practice, Good Manufacturing Practice) guidelines.
o Ability to support validation documentation, such as test plans, test scripts, and validation reports.
- Testing and Documentation
o Knowledge of validation testing procedures and the ability to document results accurately.
o Experience with creating and maintaining test documentation, logs, and records.
- Regulatory Complianceo Knowledge of relevant regulatory standards and ensuring that validation documentation meets those requirements.
- Cross-Functional Collaborationo Ability to work with technical teams (engineers, developers, QA, and project managers) to understand and document requirements, as well as support validation efforts.
- Work experience in the medical device industry
Regards
Sagar Bhardwaj
Sr. Technical Recruiter
300 Alexander Park |Suite #200|Princeton , NJ 08540
Office: +1 7324521006 Ext238
Email: sagar.bhardwaj@diverselynx.com| URL: http://www.diverselynx.com
Read more:
Daily Updated top 2000k+ VENDOR LISTS
Top 500+ USA JOBS HOTLIST
More Corp to corp hotlist
Join linkedin 58000+ US Active recruiters Network
Join No.1 Telegram channel for daily US JOBS and Hotlist Updated