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    Process Development Engineer - Santa Clara, United States - Dawar Consulting, Inc.

    Dawar Consulting, Inc.
    Dawar Consulting, Inc. Santa Clara, United States

    1 week ago

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    Description

    Our client, a leading company in diagnostics and life sciences, is in need of a Process Development Engineer. Check out the information below if you are interested.



    Job Title: Process Development Engineer


    Job Duration: Long Term Contract (Possibility Of Extension)


    Location: Santa Clara, CA


    Company Benefits:


    • Healthcare coverage (Medical, Dental & Vision)
    • Paid Sick leave
    • 401k with 2% employer match

    Responsibilities:


    • Technical Support:
    • Provide hands-on process support including troubleshooting and improvement initiatives
    • Characterize existing processes for production and testing - time, Overall Equipment Effectiveness (OEE), and cost saving initiatives
    • Create and approve Work Instructions, Production Records, and other documentation; Manage change control for updates
    • Maintain processes for production and testing; Ensure process maps and risk documents are updated
    • Participate in project teams to define and monitor process health metrics
    • Collaborate with subject matter experts for material and supplier qualification
    • Support Qualification and Validation plans
    • Continuous and Process Improvement:
    • Optimize process performance using key performance indicators
    • Lead strategic process improvement projects to reduce costs and enhance product quality
    • Build relationships across the network to leverage best practices in production and testing
    • Provide technical input on continuous improvement initiatives and inventory optimization
    • Quality Mindset:
    • Evaluate and ensure compliance for quality testing methods
    • Advise on improvements and validation methods
    • Monitor processes to demonstrate compliance
    • Lead investigations for non-compliance observations
    • Support regulatory inspections and audits
    • Formal Training/Education:
    • 5-8 years experience in Medical Device or In Vitro Diagnostics
    • BS in relevant field
    • Experience in Cartridge manufacturing, microfluidic devices, or DNA Sequencing is preferred

    If you are interested, please send your updated resume.

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