Job TitleThis is a onsite position. Local Candidates only. Years Experience: 3-6 yrs. + Manager is looking for an Engineer who has worked in medical device with an R&D background who can support Projects. Will be responsible for initiating the project to out the door. Will operate in a quality system within R&D. Will be responsible for working with cross functional teams (R&D, Quality, Regulatory) to ensure that timelines are determined and kept, budgets are approved, creating the deliverables, initiating, and running team meetings and maintaining notes.SkillsResponsible for implementing and maintaining the effectiveness of the quality systemBachelor's degree required, strongly prefer in Engineering but will consider other disciplines like Biomedical, Science or TechnicalIDEAL IS Minimum of 3 years of experience in medical device but will consider other types of "Regulatory" background like Pharma, Diagnostics, or healthcare.Must have Microsoft Office knowledge with PowerPoint, Outlook, Excel, and Word.MS Project experience is Strongly preferred and Ideal but not required.Must have great communications, be organized and a self-startedDoes not need Project Management experience ONLY if the candidate has solid exp. medical device in Product development or Regulatory working with hardware and software developmentWill be managing change ordersTop PrioritiesMedical deviceProject Management exp.R&D exp.Top 3 "Soft" SkillsOrganizedGreat communicationSelf-starter, go getterDutiesExecutes to defined business results expected from a project. Is responsible and accountable for achieving those results; where results are expressed in terms of compliance with Design Control and/or Change Control policies; quality; time; scope and cost.A project is a set of interrelated tasks that culminates in clearly defined business results.Bachelor's degree required preferably in Engineering.Exp. in medical device quality and design controls Organized Exp. in Microsoft Office toolsBeing able to understand what engineers are saying to put in project time line, schedule and run project meetings, be able to document resultsFor new product development projects; the business results will typically include the launch of one or more products.Differences across the levels of Project Manager are dependent upon increasing project complexity and increasing level of expected independence.Each higher level incorporates the expectations from the lower levels.Manage moderately complex project or several smaller low complexity projects with the assistance from their manager.Evaluates Risk/Reward Trade-offsProvides risk assessments (both safety and project related) and communicates critical issues impacting product quality to management (Q01 and Q04.01.004)).Establish and maintain risk analysis as part of overall responsibility to control / reduce risk (QO4.01.001) Recognizes strategy; quantifies and evaluates risks; recommends actions and develops contingencies to cope with various scenarios.Able to analyze risk / reward trade-offs and make recommendations of appropriate path forward.Translates Project Goals:Translates project ADD goals into the day-to-day activities necessary to accomplish them.