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    Process Development Engineer - Santa Clara, United States - Estuate Inc.

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    Description

    Job Title: Process Development Engineer

    Location: Santa Clara, CA,

    Contract 12 Months

    Onsite Position

    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
    • Partner across the client network to build relationships with the goal of leveraging best practices in production and 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


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