Systems Integration Engineer-Medical Device-FDA-DOOR-Risk Analysis
Engineering Technical Group - Santa Clara, CA

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Company Description:
Engineering Technical Group

Job Description:
Responsible for implementing and maintaining the effectiveness of the quality system.
  • Performs assignments of a very complicated or difficult nature requiring a high degree of technical competence.
  • Plans, organizes and conducts technical projects. Consolidates results of design elements of major projects for purpose of design review.
  • Conceives and plans projects to explore product or process problems; defines and selects new concepts and approaches to the design or development of new or improved products or processes.
  • Forms and suggests ideas to support the strategic technical direction of the area. Provide technical guidance to less experienced engineers, designers and technicians.
  • Formulates detailed plans for execution by other less experienced engineers.
  • Interface with product team members, PCB designers, manufacturing or design engineer, R&D, marketing, regulatory (internal), site engineering, Instrument Development managers and operations.
  • Synthesizes Proven Approaches: integrates multiple approaches to solve problems or optimize solutions in complex or cross functional manufacturing processes or product designs.
  • Creates/Modifies Subsystems Designs for Complex Problems: integrates subsystems and components in total systems designs; develops specifications from customer requirements.
  • Integrates Multiple Project Plans: establishes and reviews complex plans for multiple activities/projects or plans highly complex personal projects; monitors and takes corrective action for processes and systems.
Education:
Bachelor's Degree in an Engineering
Special Skills Needed-Test plan and protocol generation, history with medical devices,
DOORS exp,
Strong FMEA and FDA compliant Risk Analysis

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