Job Description

**This is a full-time role with the client**

Salary: $70k - $74k/year with benefits

Client is seeking individuals who combine excellent Technical Writing with the ability to function effectively both as part of a team or on an individual basis to bring their talent to our team.

Although this position is onsite in Pittsburgh, PA, candidates are required to reside within 100 miles of the Client office location in Pittsburgh, PA to accommodate training, corporate services, and other in-person aspects of the role.

Mandatory Skills: Technical Writing, CAD, and Visio.

Experience: Minimum of 2 years.

The expected annual salary for this role ranges from $65,000 to $69,000. The position is eligible for Client’s standard benefits, which include various medical and dental plan options, disability insurance, paid time off (including sick leave), and additional paid and unpaid leave options. Applications from individuals with disabilities are encouraged.

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; 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 complaint timeline requirements

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