Sr. Validation Engineer - V&V, Patient Monitoring - Draeger Medical Systems, Inc. - Job-ID V000002376

Test, FDA, Biomedical, Computer, Software, Engineering, Excel, PowerPoint, ISO, Rational, Quality, Manager
Full Time
Work from home not available Travel not required

Job Description

What will you do
At Draeger, our work is dedicated to protecting, supporting and saving lives. We are looking for a talented individual to join our patient monitoring team to help deliver new features and product enhancements that will improve patient outcomes and reduce the cost of medical care around the world.

This individual will lead verification activities for C&D projects by testing, documenting, troubleshooting and scheduling. Perform and analyze verification test data to determine compliance with product requirements and documentation of deviations. Develop verification strategies comprising of networked products utilizing industry standards and proprietary protocols.
  • Lead the verification strategy/planning/scheduling efforts as the Product Qualification cross-functional representative
  • Review product, user and technical system requirements for completeness, feasibility and testability of the product and/or system
  • Design and develop repeatable test methods/procedures and automated scripts for product & system verification taking into account both requirements-based and clinical use case-based approaches
  • Produce regulatory relevant verification documentation for the assigned project to include verification plans, specs, summaries, list of non-conformities and traceability matrices.
  • Test risk-based software and hardware design mitigations contributing to the assurance of patient safety based on product hazards descriptions.
  • Complete full traceability analysis from system requirements through product risk mappings in relation to verification specifications
  • Troubleshoot deviations observed and provide relevant diagnostic information to appropriate engineers for diagnosis. Represent Verification as part of Deviation Review Board to assign appropriate risk classification.
  • Perform work in compliance to all relevant internal SOPs and FDA/industry regulations.
  • Performs other duties as needed and assigned.

Who you are
Education: BS in relevant engineering discipline (e.g. Biomedical, Electrical, Computer, or Software Engineering).

Related Experience: 5+ years of experience in verification/testing of products. Medical device experience preferred

Special Competencies or Certifications:
  • Proficient with the use of MS Office Products (Word, Excel, PowerPoint SharePoint).
  • Knowledgeable on network interfaces and comfortable working on proprietary network protocols.
  • Prior working knowledge in a regulated industry with 510K submissions
  • Familiar with FDA, IEC, ISO regulations in relation to verification principles and patient monitoring
  • Familiarity with JIRA, Rational ClearQuest/DOORs, LabVIEW, or Quality Manager a plus
  • Ability to create robust documentation and having a strong attention to detail

**compensation commensurate with experience**
Dice Id : RTX123184
Position Id : J000004127
Have a Job? Post it