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Manufacturing Engineer/Validation Engineer

Company: Emonics, LLC
Location: Louisville
Posted on: January 26, 2023

Job Description:

-Job Role :: Manufacturing Engineer/Validation Engineer

Louisville . CO



--- Production support engineering with respect to testing methods, procedures, and problems.
--- Assist Manufacturing with device specification and yield problems, minor redesign of devices and capital system components.
--- Review and support supplier related engineering changes and optimizing device production relative to cost constraints.
--- Serve as Manufacturing Engineering representative in cross functional projects.
--- Execute change requests and align with internal stakeholders.
--- Create, Execute and Document Master Validation Plans, Process Validations, Non-product software validations and Equipment qualifications (IQ, OQ, PQ).
--- Identify, recommend, and implement continuous improvements in the workflows that support Manufacturing and kitting line.
--- Sustaining Engineering resource to prevent operational/line down issues at Suppliers assigned to this role.
--- Works as project lead to coordinate larger scale Operations projects, providing schedule, cost, and resource requirements for stakeholder consideration, communication, and execution of project.
--- Assist Manufacturing in device usage problems or testing of complex devices.
--- Provide leadership, training, and mentorship to less experienced team members.
--- Adhere to safety policies and procedures.
--- Demonstrated ability to manage and prioritize multiple tasks/projects with a strong problem-solving ability.
--- Create Engineering Reports, Validation and Qualification plans and reports to document and present results.
--- Review of Design Transfer documents and risk documents like PFMEAs

Keywords: Emonics, LLC, Denver , Manufacturing Engineer/Validation Engineer, Engineering , Louisville, Colorado

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