Jobs
>
Fremont

    Senior Manufacturing Engineer - Fremont, United States - QAPEL MEDICAL INC

    QAPEL MEDICAL INC
    QAPEL MEDICAL INC Fremont, United States

    3 weeks ago

    Default job background
    Description
    Job Description

    Job Description


    About Q'apel:
    At Q'Apel, we are passionate about revolutionizing neurovascular access. In the simplest sense, we're a company that creates solutions. We design novel access device technology for vascular interventions and unmet clinical needs. Because in the precious seconds that surround a stroke emergency, clinicians need technology that delivers. That's where Q'Apel comes in.
    Successful Q'Apel team members step up to the plate and work together to achieve our goals every single day.

    We are a fast-paced, high-growth company with a startup philosophy that requires an all-hands-on-deck attitude, taking on all changes with excitement and a great attitude.


    Who We Want:
    The Senior Manufacturing Engineer role based in Fremont, CA, will play a pivotal role in supporting various Warehouse functions. These responsibilities include

    Responsible for contributing to the design, development, and manufacturability of neurovascular products in accordance with the company's Quality System and customer requirements.

    The role is multifaceted and varied; it requires technical knowledge for assigned projects or products to ensure the design and development process is followed and will include but is not limited to design, development, verification and validation testing, transfer to manufacturing, and continuous enhancements/ improvements to the products.

    Supports the design transfer to manufacturing activities to ensure the product can be manufactured and is cost-effective/ within budget in a fast-paced environment.


    Position Responsibilities and Authorities:
    Lead the development of design specifications to assure manufacturability.
    Lead the set up and run product testing and protocols in accordance with project plans.
    Lead process and design improvement activities to gain efficiency and quality.
    Identify and support the qualification of suppliers for materials needed for products.
    Ensure product documentation is in accordance with the Quality Management System requirements.

    Provide manufacturing engineering expertise in the daily operation and maintenance of the assigned manufacturing processes and related business continuity needs in production and to contract manufacturer as needed.

    Troubleshoot and correct manufacturing processes and equipment.

    Work with Quality Engineering and Production personnel in the conduct of root cause analyses of material and process non-conformances (NCMRs) and implementation of corrective actions (CAPAs).

    Work with R&D and Production personnel to manufacture product for Design Verification and to transfer new products and processes into manufacturing environment in-house or to an external contract manufacturer.

    Provide engineering expertise to the design, fabrication, development, installation, validation, and qualification of equipment /fixtures per Quality system requirements.
    Successfully lead the process of transferring NPI products into the manufacturing environment from development.

    Support engineering testing and documentation that complies with regulatory requirements for regulatory approval or clearance by FDA or other international regulatory bodies.

    Support the Quality System and Quality Policy. Be aware of Quality System procedures and requirements, including regulatory requirements, training requirements for position. Communicate concerns involving product quality as needed.
    Other duties as assigned.

    Qualification Requirements:

    Education:
    BS Degree in Engineering or related discipline or equivalent related experience in the medical device industry.


    Experience & Skills:


    5-7 years experience in engineering or related experience in the medical device industry, preferably in the Neurovascular/ Vascular device industry.

    Strong knowledge of FDA regulations, guidelines, and policy statements.
    Effective/ Excellent verbal and written communications
    Ability to work independently or in a team setting required.
    Communicating effectively across all levels of the organization
    Works well under pressure, organized and self-motivated
    Use of critical thinking, problem solving and analysis
    Design, specify, assemble, and validate manufacturing equipment and processes.
    Use of statistical experimental design and analysis techniques.
    Use CAD software such as Auto cad, Solid Works
    Ability to travel to attend training activities, visit suppliers, etc. will be required periodically.

    Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and

    training/certifications.


    In addition to those factors, we also examine internal equity as well as consider the current market rate, and the title may be assessed one level lower or higher accordingly.

    After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary.

    The target salary range for this position is $120k- $150k USD. The pay range for this position is a general guideline only.

    The salary offered will depend on internal pay equity and the candidate's relevant skills, experience, qualifications, and job market data.

    #J-18808-Ljbffr
  • A&D Precision

    Manufacturing Engineer

    1 week ago

    A&D Precision Fremont, United States

    Job Description · Job DescriptionKey Responsibilities: · Review engineering drawings for manufacturability, identifying potential issues and recommending design changes as needed. · Collaborate with design engineers to ensure that components are designed for efficient and cost-ef ...

  • Yield Engineering Systems

    Manufacturing Engineer

    1 week ago

    Yield Engineering Systems Fremont, United States

    YES (Yield Engineering Systems, Inc.) is a leading manufacturer of reliable, high-tech, cost-effective capital equipment that transforms materials and surfaces at the nanoscale. From startups to the Fortune 50, our customers rely on YES to help them unleash products that change l ...

  • A&D Precision, Inc.

    Manufacturing Engineer

    5 days ago

    A&D Precision, Inc. Fremont, United States

    Job Description · Job Description · Key Responsibilities: · Review engineering drawings for manufacturability, identifying potential issues and recommending design changes as needed. · Collaborate with design engineers to ensure that components are designed for efficient and co ...

  • NOVA

    Manufacturing Engineer

    4 days ago

    NOVA Fremont, United States

    The Operations and Manufacturing · team at Nova is looking for a · Manufacturing Engineer to perform technical writing in conjunction with · Production personnel, Engineers and Scientists to support our industry leading metrology equipment. The Manufacturing Engineer/Technical ...

  • NOVA

    Manufacturing Engineer

    2 weeks ago

    NOVA Fremont, United States

    The Operations and Manufacturing · team at Nova is looking for a · Manufacturing Engineer · to work with our Production personnel, Engineers, and Scientists to produce our industry leading metrology equipment. The Manufacturing Engineer is responsible for the company's manufac ...

  • Sanmina-SCI

    Manufacturing Engineer

    3 weeks ago

    Sanmina-SCI Fremont, United States

    Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing ...

  • SPECTRAFORCE TECHNOLOGIES Inc.

    Manufacturing Engineer

    1 week ago

    SPECTRAFORCE TECHNOLOGIES Inc. Fremont, United States

    Manufacturing Engineer Fremont, CA Hybrid 2 / 3 days per week) 12 Months Minimum Pay Rate: $60/hr on W2 · Duties: · The Manufacturing Engineer is responsible for understanding all the complexities of the BioMES system, revise and design new electronic batch records, troubleshoot ...

  • TCI

    Manufacturing Engineer

    2 weeks ago

    TCI Fremont, United States

    Manufacturing Engineer · Location: · Fremont, California, United States · Building the people that build the world. · With platforms in HVAC and Detection and Measurement, SPX Technologies builds innovative solutions that enable a safer, more efficient, sustainable world. Thro ...

  • Zoox

    Manufacturing Engineer

    2 weeks ago

    Zoox Fremont, United States

    As our Manufacturing Engineer, you will be responsible for planning, developing, and improving our new L3 production line. You will be responsible for helping us transition towards being a more production-ready company by implementing OEM-level tools and processes. · Responsibil ...

  • Viant, Inc.

    Manufacturing Engineer

    2 days ago

    Viant, Inc. Fremont, United States

    The Manufacturing Engineering is to in close collaboration with Operations, NPI Engineering, Design & Development, and Purchasing to support Catheter Manufacturing for the Operations team. You will be involved in the design and development of fixtures and processes to scale manuf ...

  • Info Way Solutions

    Manufacturing Engineer

    1 week ago

    Info Way Solutions Fremont, United States

    Manufacturing Engineer, Process Development, Module Energy Products · Job Category Manufacturing · Location Sparks, Nevada · Req. ID · Job Type Full-time · Apply · Tesla participates in the E-Verify Program · What to Expect · As a Tesla Manufacturing Engineer, you have th ...

  • Elma Electronic

    Manufacturing Engineer

    3 weeks ago

    Elma Electronic Fremont, United States

    Elma Electronic Inc. is a global leader and industry innovator in advanced embedded computing solutions. Our products and integrated platforms are based on a set of modular building blocks such as, precision hardware components, rotary switches, and embedded computing boards. · A ...

  • Yield Engineering Systems

    Manufacturing Engineer

    4 days ago

    Yield Engineering Systems Fremont, United States

    Posted · 6 days ago · Full-time · Manufacturing · Engineering · Appliances, Electrical, and Electronics Manufacturing · Semiconductor Manufacturing · Meet the hiring team · Rachel Hyon · People & Culture Administrator at Yield Engineering Systems · Job Poster · About the jo ...

  • NOVA

    Manufacturing Engineer

    3 weeks ago

    NOVA Fremont, United States

    The Operations and Manufacturing team at Nova is looking for a Manufacturing Engineer to work with our Production personnel, Engineers, and Scientists to produce our industry leading metrology equipment. The Manufacturing Engineer is responsible for the company's manufacturing pr ...

  • Velo3D

    Manufacturing Engineer

    3 weeks ago

    Velo3D Fremont, United States

    Velo3D is a technology company that provides the industry's most advanced fully integrated metal 3D printing solution for mission-critical parts. · Some of the most pioneering companies, including SpaceX, Honeywell, and Lam Research, use the Velo3D solution to drive defense innov ...

  • NOVA

    Manufacturing Engineer

    3 weeks ago

    NOVA Fremont, United States

    The Operations and Manufacturing team at Nova is looking for a Manufacturing Engineer to perform technical writing in conjunction with Production personnel, Engineers and Scientists to support our industry leading metrology equipment. The Manufacturing Engineer/Technical writer i ...

  • Elma Electronic

    Manufacturing Engineer

    2 weeks ago

    Elma Electronic Fremont, United States

    Elma Electronic Inc. is a global leader and industry innovator in advanced embedded computing solutions. Our products and integrated platforms are based on a set of modular building blocks such as, precision hardware components, rotary switches, and embedded computing boards. · ...

  • CalTek Staffing , Inc.

    Manufacturing Engineer

    1 week ago

    CalTek Staffing , Inc. Fremont, United States

    3-6 month contract. Pay is $40-$50/Hour · The Manufacturing Engineer is involved in the design of the company's manufacturing/quality processes and once the process is in place, this individual is responsible for running and maintaining the process as well as seeking ways to con ...

  • CalTek Staffing , Inc.

    Manufacturing Engineer

    1 week ago

    CalTek Staffing , Inc. Fremont, United States

    3-6 month contract. Pay is $40-$50/Hour · The Manufacturing Engineer is involved in the design of the company's manufacturing/quality processes and once the process is in place, this individual is responsible for running and maintaining the process as well as seeking ways to cont ...

  • TCI

    Manufacturing Engineer

    3 weeks ago

    TCI Fremont, United States

    · Manufacturing Engineer · Location: · Fremont, California, United States · Building the people that build the world. · With platforms in HVAC and Detection and Measurement, SPX Technologies builds innovative solutions that enable a safer, more efficient, sustainable world. T ...