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San Francisco Bay Area, CA

  • Manufacturing Engineer II

    Position Summary:

    Manufacturing Engineer owns the manufacturing content for new product introductions. Participates in product development teams that specify, build, test and challenge new product designs to improve efficacy, reliability, serviceability, manufacturability and cost.

    Authorities:

    • Has the authority to identify and record problems relating to product and component design and to recommend or provide solutions. Interface with contract manufacturers, engineers and technicians. Interface with vendors, order parts, materials. Support Manufacturing and R&D goals.

    Duties and Responsibilities:

    • Designs, qualifies, documents and introduces production and service assembly/test electromechanical fixtures and equipment.
    • Takes ownership of new products during pilot production phase through successful and sustained project launch. This includes driving new product introduction schedules, escalating and resolving manufacturability issues.
    • Helps to create an efficient “mid-volume” manufacturing assembly line, specifying and/or refining BOMs, work flow processes and detailed work instructions.
    • Provides product and process DFM (Design for Manufacturing) input to Product Development Engineering to enhance manufacturability and servicing.
    • Responsible for maintaining compliance with medical device quality system requirements including corrective action closure, discrepant material dispositions and ECO implementation.
    • Provides technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns.
    • Leads/participates in initiative focused on material cost reduction, capacity enhancement, outsourcing of assemblies, etc.
    • Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing organizations.
    • Provides training and support to production technicians.
    • Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.
    • Responsible for component documentation
    • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
    • Maintain clean and orderly work/ lab space.

    Position Requirements:

    • 4 yr. degree in Mechanical Engineering or equivalent.
    • Demonstrated Electromechanical and/or Process Engineering capability.
    • Solid model experience a must (SolidWorks).
    • Strong foundation in design, fabrication and assembly of complex assemblies.
    • Demonstrated ability to effectively design experiments.
    • Excellent communication and documentation skills.
    • Demonstrated ability to represent the company to its partners, suppliers, and vendors.
    • Comfortable interacting with technicians, engineers, and management.
    • Strong technical skills in prototyping and troubleshooting from engineering documentation.
    • Demonstrated ability to successfully work on multiple projects at once.
    • ISO9001 or experience in medical device manufacturing environment.
    • Moving or lifting equipment/product up to 30 lbs. occasionally required.
    • Machine tool experience a must.
    • Should be able to travel overseas 25%.


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