Technical Writing, CAD, and Visio

Overview

On Site
$60,000 - $69,750
Full Time

Skills

CAD
Visio
Medical Device
Technical Writer

Job Details

Principal Responsibilities:

At least 2 years of experience as a Technical Writer (including SOP, QMS, CAPA 8D) in the medical device industry

Practical knowledge of applicable standards and regulations for the medical device sector

Experience with CAD and Visio

Background in Trackwise or Webtrader is preferred

Experience with PLM and EQMS tools (please indicate)

Familiarity with the CAPA 8D process, including investigation, documentation, and closure

Knowledge of design development stages, including input, validation plans and reports, root cause analysis, and complaint processes

Ability to create trending reports and prioritize repairs by severity

Experience in technical writing for design plans and reviews, DFME (Design Failure Mode Examine), DHF remediation, and risk management corrective actions

Proficiency in documenting all stages of medical device design and development, including design input, review, output, verification, validation, and transfer

Training on client products, SOPs, and templates will be provided. Additional duties include:

Maintaining a backlog of change requests to QMS design controls procedures/WIs/forms, responding to CAPAs, or for process improvements

Planning and executing procedural updates and gaining cross-functional alignment

Updating procedures and releasing them according to document change protocols

Planning and implementing training and coaching programs

Coordinating with cross-functional teams and collecting feedback from project teams

Demonstrating effective communication skills and attention to detail

Background and Skills Required:

Bachelor s degree, preferably in Engineering; a Mechanical Engineering degree is advantageous

Understanding of CAPA and global medical device regulations such as 21 CFR Parts 803, 806, and 820, and ISO13485

At least 3 years of experience writing medical and technical narratives

Experience with CAD and Visio

Experience in design quality assurance for medical devices is preferred

Strong computer proficiency, critical thinking, problem-solving, analytical abilities, and attention to detail

Capability to work independently within established guidelines to meet the complaint timeline requirements

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.