N96

Job Title: Technical Writer – Medical Device / Engineering Documentation
Location: Onsite - State College, PA
Job Type: Contract
Shift: 1st Shift

QUALIFICATIONS

• Associate degree (or equivalent experience) in technical writing, engineering, or related field.
• Experience in medical device, healthcare, or other regulated industries required.
• Strong understanding of compliance-driven documentation practices (FDA, ISO 13485 preferred).
• Proficiency with Microsoft Office and Adobe Acrobat; PLM/document control systems experience is a plus.
• Excellent written and verbal communication skills, with the ability to simplify complex technical concepts.
• Strong organizational skills and ability to collaborate with cross-functional teams.
• Must be able to work onsite.

ABOUT THE ROLE

We are seeking a Technical Writer to support a Development Engineering team. This role focuses on creating and updating documentation in a regulated environment, ensuring compliance with industry standards and quality requirements. You will collaborate with engineering, manufacturing, quality, and other cross-functional teams to produce accurate, clear, and compliant documentation.

KEY RESPONSIBILITIES

• Develop and update product documentation: specifications, risk assessments, test/validation plans and reports, assembly and process procedures, and user guides/manuals.
• Revise and migrate legacy documentation into the PLM system (ECR/ECO workflows).
• Collaborate with engineers, SMEs, and end users to gather information and ensure accuracy.
• Ensure all documents meet regulatory, quality, and company standards.
• Participate in documentation reviews to identify improvements and ensure completeness.
• Support translation processes for multilingual documentation when needed.