Validation Engineer (Software / Hardware) – 8239

Raeder Landree, Inc.

Finders of Keepers

We are seeking a talented Quality Verification and Validation Engineer to join our expanding team. The Quality Verification and Validation Engineer will develop both software and hardware verification and validation testing plans, protocols, and reports to ensure compliance with specified requirements/regulations. This position will also be responsible for ensuring quality improvement with respect to software and hardware testing for controlled release in accordance with corporate policy. This position requires not only a structured and systematic approach to implementation of V&V plans for both software and hardware, but and understand of how to apply specification and standards to these methodologies. Being able to work across disciplines but have and demonstrates creativity and resourcefulness while supporting the corporate principal. (Essential Duties): •      Consults with management, assesses customer requirements, and studies product characteristics to select verification and validation objectives and standards. •      Prepares protocols for verification and validation or performance testing of new or modified manufacturing equipment, processes, or systems. •      Analyzes data from verification and validation tests to determine whether systems and processes meet required criteria and specifications. •      Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing. •      Identifies root causes of development and production problems. •      Identifies non-conformities of product or process standard and offers recommendations for resolving deviations. •      Develops and maintains databases for tracking test results, validation activities, orvalidated systems. •      Develops,maintains, or reviews of verification and validation for compliant documentation including schematics, protocols, and change notices. •      Modifies testing methods or revisits test objectives and standards to resolve testing problems. •      Calibrates equipment to ensure accurate measurements. •      Write,refine, and administer software testing Procedures and Work Instructions in accordance with the corporate system. •      Manage and determine software and hardware testing needs for all current projects •      Attend Project SCRUM and Agile meetings as required. Knowledge,Skills & Abilities:  •      Demonstrate strong planning, organizational, statistical, and technical analysis skills •      Implementation and understanding of working within a risk-based system. •      Ability to initiate and follow through with planned objectives in a goal-driven environment •      Proficient in technical writing •      Capable of working independently and as a team; capable of building strong internal and external relationships •      Ability to multi-task, prioritize work, and investigate and resolve issues with minimal supervision •      Proficient in Jira script development •      Proficient with Microsoft Office Suite and other applications Experience/EducationRequirements:   •      Bachelor’s degree in Electronic Engineering or computer science or a related field •      Minimum of 4-10 years relevant experience required. Advanced education may be substituted for experience. •      Experience with QMS Systems (ISO 13485 or ISO 9001) is preferred •      Experiencewith ISO 14971, IEC 60601, ISO 62366, and IEC 62304 •      Experience with quality methods, tools, and concepts •      Experience within a Life Cycle product development structure is preferred •      Experience with Software and hardware Testing development •      Experience with or knowledge of SCRUM or Agile software development processes. WorkingConditions/Physical Demands:  •      Perform sedentary work – exerting up to ten pounds of force occasionally. Sedentary work involves sitting most of the time •       See, hear, talk, and perform tasks requiring manual dexterity, standing, walking and other similar tasks requiring physical activity •       Operate standard office equipment including a computer, copier, fax, phone, and other similar office equipment •      Must adhere to all Personal Protective Equipment (PPE) requirements


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