Engineer V # JN -072021-67695

Industry: Database Administrator / Engineers
Job Number:

Title                         : Engineer V

Location                 : Plano TX

Duration                 : 10+ months contract with possible extension


Job Description:

  • Gathers and analyzes input requirements and translates these into specific system, software and hardware requirements/interface specifications. Participates in broad cross functional review of work output. Updates and maintains feature specifications for one major project and may support one or more minor project.
  • Synthesizes all gathered information together with technical and regulatory constraints in order to define a system and its behaviour resulting in defining a system specification.
  • Performs technical planning and performance evaluation studies, conducts technology assessment activities, analyzes system integration issues, generates initial baseline interface specifications, estimates costs and risk, and evaluates customer satisfaction through testing (alpha and beta), analysis and studies.
  • Assign implementation of requirements to development teams and determine how systems will be architected and implemented. Provides guidance and leadership to development teams.
  • Evaluates prototypes formally and informally through structured and ad hoc testing. Test aspects of new projects or algorithms to evaluate prototypes and validate output to meet intended use requirements.
  • Investigates and defines system features and works with other engineering disciplines to ensure proper implementation. Assesses the clinical and system risks of the new features and identifies potential interactions with existing ones.
  • Author and execute system integration and verification plans, procedures, and report. Help lead a large team in the ViV efforts.
  • Identifies and resolves issues, escalating as appropriate.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.


Skills Required:

  • Bachelors Degree in Biomedical Engineering, Electrical Engineering, a related engineering field or an equivalent combination of education and work experience
  • MINIMUM 10 YEARS in relevant, progressively more responsible work experience in medical product development and/or a graduate degree with relevant project experience.
  • MINIMUM 6 YEARS core systems engineering experience.
  • Medical device (Class III/Class II) industry experience.
  • Demonstrated ability to apply an expert understanding of clinical application to issues in order to bring tasks to resolution within assigned projects.
  • Demonstrated ability to effectively integrate information from varied disciplines including Engineering, Marketing and Regulatory Affairs required.
  • Experience with Sustaining Engineering
  • Experience working in a broader enterprise/cross-division business unit model.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.


Preferred Skill:

  • Masters Degree in relevant discipline/concentration, including Biomedical Engineering.


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