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Southern California

  • Project Engineer, Sustaining

    Description
    • Develops, implements and improves manufacturing processes in accordance with product specifications and quality standards. Recommends and implements improvements to production processes, methods and controls. Coordinates manufacturing launch of new or revised products.
    Job Responsibilities
    • Assists in streamlining the process of transitioning a product from development into production.
    • Makes recommendations for product improvements from the perspective of production.
    • Develops a timetable and plan for production, assesses prototypes, and researches potential material sources.
    • Provides technical and customer support following the release of product specifications and requirements.
    • Tooling design and process development.
    • Engineering design and process development.
    • Generates intellectual property, write invention disclosures.
    • Supervises technicians, specialists, and associate engineers.
    • Specifies and/or directs the specification and testing of new materials and designs.
    • Confers with appropriate departments, resources, and/or outside services to prepare design modifications, clarify problems and develop designs.
    • Largely self-directed, capable of meeting project goals with minimal supervision.
    Qualification requirements
    • Expertise with medical device engineering equipment and processes.
    • Design and development of medical devices.
    • Reading and preparing technical documentation.
    • Working knowledge of standard machine shop equipment and processes and medical device manufacturing equipment and processes.
    • Experience working with ISO requirements, FDA regulations, medical device design control and manufacturing scale-up processes.
    • Computer skills including Word, Excel and AutoCAD (Solidworks proficiency required).
    • BS degree in related field.
    • 3 years related medical device experience.
    • Good communication skills.


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