Medical Device Engineer || Puerto Rico, TX (Onsite)

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

1. 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).

2. 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.).

3. Version Controlo Familiarity with tools like Git, SVN, or SharePoint to manage document revisions and updates.

4. 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.

5. 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

1. 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).

2. 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.

3. 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.

4. Regulatory Complianceo Knowledge of relevant regulatory standards and ensuring that validation documentation meets those requirements.

5. 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.

6. 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