Senior Medical Device Quality Engineer

Lead medical device quality engineering with FDA compliance, electromechanical expertise, and design verification experience at ECI. Contract or full-time employment is available.This senior engineering role supports life sciences consulting projects from concept through commercialization. You will guide quality decisions, documentation, design reviews, testing, validation, and regulatory compliance. The work emphasizes medical devices, quality systems, and systematic problem solving.Key Responsibilities:
Provide quality input for design decisions and project deliverablesDevelop quality plans, procedures, and regulatory documentationLead acceptance activities, inspections, testing, and criteriaPerform quarterly gap analyses and review verification documentationSupport CAPA, NCRs, complaints, and special projectsRequirements:
Four year degree and five to six years direct R&D experienceMedical device experience with electromechanical devicesCardiac pacemaker, monitoring system, and battery experienceKnowledge of FDA quality systems regulations and standardsExperience with SPC, DOE, GR&R, FMEA, CAPA, and validationApply engineering, quality systems, and FDA compliance expertise to challenging medical device programs supporting ECI’s consulting clients.
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