Product Development Engineer

Product Development EngineerHot JobXeridiem - Tucson - Tucson, AZ 85714OverviewPosition Type Full TimeDescriptionJOB PURPOSE:To design new devices/components and make design changes or improvements to existing devices/components. Leads or is a team member on projects to bring new designs or design changes through the applicable phases of the Product Development Process.ESSENTIAL DUTIES:Functions as leader or team member for projects involving all phases of product design and development, leading Core Team through the execution of project activitiesDrives execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing productionApplies the Risk Management Policy to the development process for identifying hazards, estimating and evaluating associated risks, controlling these risks and monitoring the effectiveness of risk controlsOptimizes design and technology to drive innovation and significantly improve patient outcomeEnsures all applicable aspects of product design including design for manufacturability, scalability, testing, variability, and usabilityDiligently develops product requirements and design inputs based on the applicable standards as well as other relevant sources, such as Post-Market SurveillanceOversees and participates in creation of sub-assembly and final assembly drawings to serve as design specifications for a medical deviceDevelops verification and validation plans for the protocols, test methods, and reports for execution of design verification and validation testingVerifies connection between product requirements, design inputs, design outputs, and verification/validation is clear in traceability matrixLeads and ensures thoroughness of risk management activities as documented in Risk Management File, dFMEA, and pFMEA (design/process Failure Mode Effects Analysis)Evaluates and designs products, parts, or processes for cost efficiency to minimize the cost for patient careCoordinates project activities for Commercial Release of product and corresponding manufacturing processes while meeting expectations for sustainable, efficient, repeatable, and reproducible manufacturing operationsDefines activities for project execution to meet the requirements of the Product Development ProcessSupports requests for quotes by outlining necessary project activities and timing for new product introductionUpholds SPG and Dupont vision and core valuesPerforms all other duties as assignedQualificationsQUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)Required:3-7 years industry experienceDemonstrated history to problem solve, identify errors and deficiencies and perform researchHigh degree of understanding of ISO 13485 requirements for Design ControlsAbility to provide guidelines and instructions applicable to the job functionAccuracy, attention to detail, and thoroughnessProficient computer skillsProficient communications skillsAbility to comprehend and comply with company safety and quality standardsAbility to provide oral and written instructions to othersPreferred:Master's degree in Engineering disciplineExperience as project manager on a project which involved all phases of product design and development, leading Core Team through the execution of project activitiesKnowledge on developing full-scale project plansEffectively communicated project expectations to team members and stakeholders in a timely and clear fashionExperience planning and driving execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing productionHas knowledge of commonly used concepts, practices, and procedures within medical device design and developmentCan handle financial responsibilities for project such as budget accountability and revenue recognitionExperience developing Gantt Charts in Microsoft ProjectDemonstrated ability to complete product design transfersWORKS WITH SUPERVISION FROM MANAGER AS NECESSARY. REQUIRES LIGHT PHYSICAL ACTIVITY PERFORMING NON-STRENUOUS DAILY ACTIVITIES.