Software Validation Engineer I #JN -042021-62770

`, Pennsylvania
Industry: Mechanical / Manufacture / Electrical Engineers
Job Number: JN -042021-62770


  • The Software Validation engineer will provide software validation support and guidance to ASD division for applications developed by for medical products, or software used by manufacturing and quality systems.
  • This position will be part of a team that is actively involved in the product development cycle, from an early design stage, by helping define or update user needs and software requirements specifications, and participating in product risk assessments, code and design reviews and developing the set of software validation documents.
  • This role will also be responsible for auditing software applications and supporting multiple locations. The Software Validation Engineer will be responsible for following the guidelines of the corporate validation policy and for informing management whenever changes are needed to a software validation.


Education And/or Experience:

  • Minimum of Bachelor’s degree in Computer Science, Engineering, Science, or equivalent.
  • Experience with software validation – for both product and non-product software – in the medical device industry and knowledge of FDA software validation guidelines; Experience with IQ, OQ, and PQ for software validations is required
  • Experience in product risk assessment, requirements management and tracing, defect tracking, configuration management techniques
  • Develop and document software validation protocols, document software errors and anomalies
  • Working knowledge of application software development lifecycle, and understanding of functional testing methodologies (white box, black box, positive, negative, boundary, and regression) is preferred.
  • Create and update Standard Operating Procedures (SOPs) and other software validation-related system design documents
  • Working knowledge of the development of medical devices in conformance with Quality System Regulations, IEC 62304, IEC 62366, ISO13485, and ISO14971 standards
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


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