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San Francisco Bay Area, CA

  • Senior Manufacturing Engineer

    San Jose, CA

    Summary:

    Plans, directs, coordinates, and executes manufacturing engineering activities related to new product development and sustaining existing product by performing the Essential Duties as listed below. This position will create a line extension for an existing disposable catheter product (catheter experience is a requirement). Will also work with Navigation systems and therapeutic systems in development and on the market.

    Essential Duties and Responsibilities: (Other duties may be assigned)

    • Develops, evaluates, and documents manufacturing methods for new products in development. Owner of authoring documentation required for finished goods production.
    • Partners with design staff concerning product design and process designs to ensure efficient, repeatable and cost-effective production methods.
    • Develops and drives process validation of new products or repeat validation of existing products. Drives authoring of protocols, completion of testing, and authoring reports to support validation and transfer phases of development.
    • Design, plan, and support transfer to foreign MFG facility or contract manufacturer as required by business plan.
    • Troubleshoots mfg. issues and is owner of research, testing and/or analysis to resolve. Implements resolution in DMR with required justification and background to support.
    • Analyzes space requirements, workflow, and designs layout of equipment and workspace for maximum efficiency
    • Mini Design Projects such as accessories to existing products, redesign of sub parts to large assemblies or cost reductions.
    • Leads resolution of manufacturing and process issues.
    • Applies statistical methods where required by standard or standard practice. Applies statistical methods such as DOEs to understand manufacturing requirements and improve processes.
    • Provides technical support to the Purchasing and Quality Assurance for supplier selection, cost negotiation, and quality problem resolution.
    • Responsible for managing projects associated with tooling and fixturing, automation, manufacturing processes, process improvement, cost containment, yield improvement, and scrap reduction.
    • Interacts with vendors to determine or refine specifications and arranges for purchase of equipment, materials, or parts, and qualifies processes as required.
    • Responsible for IQ, OQ of capitalized business equipment, and critical manufacturing equipment, fixtures and tools.
    • Supports the regulatory submission process in compliance with all ISO, EN, MDD and FDA regulations and requirements by gathering data, assisting in the completion of submissions, and meeting goals set forth by project management
    • Responsible for development of manufacturing support documentation, working with engineers to identify best-fit suppliers and sourcing of materials to ensure product quality, cost, manufacturing and delivery requirements are met.

    Qualifications:

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

    Education/Experience:

    BS degree in engineering with minimum of 6 years experience or AA with minimum of 8 years of experience. Must have 3+ years of hands-on medical device experience. Must be able to multi-task and operate in a fast startup environment with minimal training and supervision.

    Language Ability:

    Ability to read, analyze, and interpret manufacturing instructions, CAD drawings, spreadsheets, business memos, reports, technical procedures, and simple legal documents. Ability to write protocols, reports, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers and customers. Ability to respond to general inquiries or complaints from production staff and other team members. Ability to effectively present information to top management.

    Reasoning Ability:

    Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables simultaneously.

    Computer Skills:

    Word processing, spreadsheet, Internet, e-mail, manufacturing, and Solidworks or other CAD

     


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