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    Medical Device Product and Process Development Engineer - Santa Clara, United States - Estuate Inc.

    Estuate Inc.
    Estuate Inc. Santa Clara, United States

    3 weeks ago

    Default job background
    Description
    Relevant Experience: 5-8 years in Medical Device or In Virtro Diagnostics

    Education:
    BS in relevant field.

    Prior Experience:
    Cartridge manufacturing, microfluidic devices or DNA Sequencing is preferred.


    Technical Support:

    Provide hands-on process support including troubleshooting and improvement initiatives
    Support effort to characterize existing processes for production and testing - time, Overall Equipment Effectiveness
    (OEE), optimization and cost saving initiatives
    Create and approve Work Instructions, Production Records, and other documentation for processes; Managing change
    control for updates to production documentation
    Maintains processes utilized for production and testing to ensure process maps are up to date and process risk
    documents are updated to represent current controls
    Participate in project teams to define and monitor process health metrics (KPIs, key performance indicators)
    Partner with functional subject matter experts to support material qualification, supplier qualification, and actively manage
    issues found with incoming materials
    Support development of Qualification and Validation plans and take an active role in protocol executions

    Continuous and Process Improvement:
    Actively seek opportunities to optimize process performance leveraging key performance indicators and lead important
    strategic process improvement projects to drive down costs and improve product quality
    testing excellence (i.e. LEAN practices and Design for Quality and Manufacturability)
    Assess and provide technical input on continuous improvement initiatives and inventory optimization


    Quality Mindset:

    Partnering with MSAT colleagues and Operations Quality Stakeholders to maintain the qualified state of existing
    processes
    Evaluate, advise, and ensure compliance for quality testing methods to optimize time, cost, and effort needed to execute
    necessary methods - advise on improvements and ensure controls are demonstrated through completion of method
    validation, spreadsheet validation, or computer system validation
    Ensure continuous monitoring for processes per quality system requirements to demonstrate ongoing compliance
    Support or lead investigations for identified non-compliance observations (for example, Corrective and Preventative
    Actions (CAPAs) and Non-Conformance Reports (NCRs)) and provide technical input as needed to remediate
    discrepancies
    Support regulatory inspections and audits by providing technical expertise and documentation as needed
    Other duties as assigned by management
    Medical Device Product and Process Development Engineer
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