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Hayward

    Senior Manufacturing Engineer - Hayward, United States - Bayside Solutions

    Bayside Solutions
    Bayside Solutions Hayward, United States

    2 weeks ago

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    Description

    Senior Manufacturing Engineer

    Direct Hire Full-Time Role

    Salary Range: $125,000 - $140,000 per year

    Location: Hayward, CA - Onsite Role

    Job Summary:

    As a Senior Manufacturing Engineer, you will be responsible for manufacturing engineering, production, product support, and servicing to achieve world-class results for durable and disposable products.

    Duties and Responsibilities:

    • Drive manufacturing engineering and work closely with R&D and Quality to effectively transition products to manufacturing, serving as a key representative and contributor on a project development team.
    • Champion New Product Introduction (NPI) activities and actively mentor and support the development team to ensure the completion of company objectives.
    • Lead capital, durable, and disposable product transfers through to low-volume and high-volume production.
    • Lead operation process definitions, including hands-on specification of MPIs, TPs, and DHRs.
    • Conduct PFMEA analyses; define and execute process validations.
    • Work with external contract manufacturers.
    • Contribute to operation initiatives, applying analytical and statistical methods to improve quality, reduce cost, reduce cycle time, and simplify processes.
    • Review and interpret engineering drawings and technical reports (tolerance stack analysis, technical justifications, etc.).
    • Provide SME guidance to Engineering for product manufacturability and design transfer.
    • Provide technical expertise and mentor other engineers and technicians on the team.

    Requirements and Qualifications:

    • A bachelor's degree in engineering, manufacturing, industrial engineering, or a related discipline is required.
    • 5+ years of experience in one or more disciplines of manufacturing operations (e.g., manufacturing, assembly and test, manufacturing engineering, subcontract, service) with a minimum of 3 years of experience in the Life Science or Medical Device industry
    • Tooling and fixture design background is desired.
    • Technical knowledge of assembly and test disposable and/or capital equipment.
    • Knowledge of manufacturing engineering, ERP and PLM systems, quality assurance, and lean manufacturing processes
    • Able to travel to Contract Manufacturers for process development, training, etc.
    • Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other national and international regulations and standards.
    • Experience at start-up companies is preferred.
    • Controlled environment room (CER) experience is desired.
    • SolidWorks, MiniTab, Zebra Printer hardware and software
    • Proficient knowledge and skill in Microsoft Office Suite applications (Word, Excel, Project, PowerPoint, Visio)
    • Excellent oral, written, and presentation communication skills and critical thinking skills
    • Able to lead team activities and provide SME guidance to resources inside and outside operations.
    • Able to work as a team member, multi-task, and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast-growing company.
    • Able to travel up to 15% of the time. Overnight or international travel may be required.
    • Able to lift 10-15 pounds.

    Desired Skills and Experience

    Manufacturing Engineer, Medical Device, ERP, PLM, FDA, SolidWorks, MiniTab, Zebra Printer, Microsoft Office, travel

    Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at

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