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Wilmington

    Mechanical Design Engineer - Wilmington, United States - Gentis Solutions

    Gentis Solutions
    Gentis Solutions Wilmington, United States

    1 week ago

    Default job background
    Description
    Job DescriptionJob Description

    Gentis Solutions is seeking a Mechanical Design Engineer for a direct hire full-time position with one of our clients. The ideal candidate will be able to apply their knowledge in product development and engineering sustaining activities. If you are qualified, make sure you apply.

    Requirements

    Bachelor of Science degree in Mechanical Engineering

    Exposure to and/or basic engineering understanding of principles associated with electro- mechanical/hydraulic

    devices to include DC motor, pump, cylinder, valve body and control system design

    Exposure to and/or basic engineering understanding of basic design principles related to injection molding, metalworking, machining, castings, aluminum extrusions, welding, battery technologies, and electrical systems

    (PCB/Firmware/Software)

    Exposure to and/or basic engineering understanding of ISO and FDA-regulated design control requirements for medical devices

    With direction, ability to make decisions in regard to compliance, product reliability, and analysis of testing methodologies

    Working knowledge of SolidWorks CAD Software as it pertains to mechanical system layout

    Working knowledge of GD&T/ANSI standards

    Strong product affinity and results orientation

    Typical Duties

    Engineering design team member of electro-mechanical pre-hospital patient handling products and sub-systems

    Design and re-design of FDA, ISO 13485, CE, ISO 14971, MDD 93/42/EEC, MDR compliant medical devices

    Participate in Engineering Change Order and/or Phase-Gate processes for assigned programs to include QMS compliance

    Participate in the formulation of design specifications, material specifications, concept, prototyping, tolerance stack-ups, DFM, DFA, DFS, vendor integration, design reviews, FMEA development, usability assessment, design transfer readiness and introduction

    Accountable for design history file and technical file documentation and other controlled documents under regulatory framework

    Review product verification and validation test plans and results. Provide feedback to development teams

    Work with test engineering, quality and regulatory to ensure products maintain certification to various standards

    Lead communication on assigned programs and provide issue escalation support to internal and external customers

    Maintain and update design drawings and models utilizing CAD; Solidworks experience is required

    Conduct design reviews for updated legacy or new product designs

    Assist in diagnosing field issues and developing corrective actions

    Ensure compliance with all regulatory and compliance activities within prescribed area

    Develop solutions to improve product quality and reduce product cost

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