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Mechanical R&D Engineer
Job Location :
560 Cottonwood Drive
Milpitas, California 95035
United States
Stellartech Research Corp
560 Cottonwood Drive
Milpitas, CA 95035
United States
Employment term : Full Time
Degree : Bachelors
Travel : Yes
Job level : Mid Level 2-6 yrs.
Work Authorization :
  • Authorized to work
  • Looking for a Mechanical Engineer to join our Team.

    Responsibilities:

    • Develop mechanical and electromechanical medical systems that include a disposable patient contact device, primarily made from plastic, and may interface to an electronic instrument. 
    • Create and/or translate component/subassembly/product requirements into measurable specifications.
    • Determine sub-system and component design and performance requirements.
    • Design or source required sub-systems and components and help integrate then into the final product.
    • Assist with product/component design verification and system validation.
    • Assist with development activities required for product marketing including packaging and labeling, materials selection and biocompatibility testing, etc.
    • Write technical reports to support regulatory agency approval(s) (e.g. US FDA).
    • Assist with creation of Device Master Records, including specifications, manufacturing procedures, quality instructions, and test procedures.
    • Assist with transfer into manufacturing, including equipment, tooling and fixture development, process development and process validation.
    • Assist with training of manufacturing and quality engineers, assemblers, technicians and other support personnel.
    • Create and/or augment documentation in the Design History File.
    • Maintain records of ideas, developments and test results in a bound notebook.
    • Assist with preparation of documentation to support proprietary information development.

    Skills & Qualifications:

    • Typically requires a BS degree in Mechanical Engineering. At least 3-5 years of Mechanical Engineering experience.  Familiarity with plastics and their fabrication processes (e.g. extrusion, injection molding, machining {lathe turning and milling}, adhesive bonding, etc.). Experience using Solid Works or other solid modeling software, and general machine shop experience (e.g. lathe, mill, hand tools, etc.). Medical Device experience is desired.


    Stellartech Research Corp Profile:

    Stellartech was founded in 1988 by Roger A. Stern, Ph.D. to develop innovative electronic devices for start-up companies in the medical industry. The company has grown steadily over the years, and has built a strong reputation based on its expertise in the development and manufacture of complex energy delivery systems and other sophisticated medical equipment.

    In the late 1990’s, Stellartech’s capabilities expanded to include design and manufacture of disposable devices. Today Stellartech employs over 110 people in its state-of-the-art facility in the heart of Silicon Valley.

    A pioneer in energy-based therapies, Stellartech is responsible for the development of many “firsts” in the medical device industry, including:

    • The first temperature controlled RF generator for cardiac ablation (U.S.)
    • The first monopolar capacitive RF tissue remodeling system for cosmetic use
    • The first balloon-based system for esophageal ablation
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