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    Principal Mechanical Engineer - Campbell, United States - Telos Health

    Telos Health
    Telos Health Campbell, United States

    1 week ago

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    Description

    Job Title: Principal Mechanical Engineer, Fluidics
    Location: This position is based in our Campbell, California offices.

    Why Telos Health?
    At Telos Health we are developing novel robotic-assisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke – a disease that impacts close to a million people a year in the U.S., and 10 million worldwide. Not only is Telos changing the way stroke is treated, but also bringing this treatment to the greater population who is currently without. We are actively building a team who is focused on developing novel solutions for this complex disease – a disease in which one in four adults will face in their lifetime.

    What You'll Do:
    This position will lead the design and development activities for the consumable devices and related accessories that will be used with the Fluidics System as part of the Telos Health robotic-assisted aspiration thrombectomy platform. This position will participate in creative brainstorming, conceptualization, and prototyping of new devices independently and in conjunction with other engineers and external partners, with a specific focus on unique sterile, single use syringes, tubing, stopcocks, manifolds, haemostasis valves, and related devices, components, and assemblies. Responsibilities will include problem solving, device design and development, hypothesis testing, test method development, design documentation, specification setting, prototyping, device testing, data analysis, and report generation. Project responsibilities will extend from early conceptualization through verification and validation testing, as well as transferring the projects to manufacturing to support commercial release.
    • Work within a multi-disciplinary team, and closely with the capital equipment engineer(s) to identify specific clinical and device performance needs, appropriate specifications, and to develop appropriate design inputs and outputs.
    • Lead in the creation of detailed specifications, prototypes, and testing of new products, identifying, and collaborating with external suppliers and contract developers/manufacturers, as applicable, to ensure high quality and performance.
    • Ensure that assigned projects and/or products are designed to facilitate manufacturability and cost constraints, and lead technology transfer to internal or external manufacturing (to include development of manufacturing tools and/or aids as necessary)
    • Lead brainstorming sessions to generate new intellectual property and work with senior staff and/or attorneys to write and research patent claims.
    • Execute bench studies, experiments, and product testing, in accordance with protocols and project plans; collect, compile, and assess test data to derive technical conclusions and decisions; and create and release test reports.
    • Create and maintain documentation including design drawings, testing reports, engineering reports, and other technical documents in accordance with quality system requirements.
    • Oversee the activities of technicians and more junior level engineers in completing device testing/inspection and prototype construction, as applicable.
    What You'll Bring:
    • Bachelor's or master's degree in Engineering (Mechanical, Biomedical, or related discipline) with 12+ years of related experience with BS degree or 8+ years with MS or Advanced degree; or equivalent combination of education and work experience in the medical device or related regulated industry.
    • 5+ years previous experience in a technical innovation role, with specific focus on the design, development, manufacturing, and testing of sterile, single use medical device related injection moulded consumable components, devices, and/or assemblies, such as high-pressure tubing, haemostasis valves, stopcocks, fluid fittings, manifolds, and fluidics cassettes.
    • Knowledge of fluid flow properties and test methods
    • Strong understanding of fabrication methods including machining, sheet metal, rapid prototyping, extrusion, adhesive and solvent bonding, and injection moulding, and materials associated with each method.
    • Experience and familiarity with statistical methods such as such as SPC, SQC, and DOE and use and implementation of Statistical Analysis Software (Minitab or similar)
    • Proficiency using SolidWorks, for designing and documenting device designs, tooling, and fixtures
    • Ability to complete projects individually as well as lead projects as part of a multi-disciplinary team.
    • Extensive experience in full R&D product life cycle (concept through regulatory approval/market release)
    • Experience with Design Control procedures and requirements and working under regulated quality systems such as GMPs, ISO 13485, and MDR
    • Demonstrated excellent written and verbal communications skills as a member of a cross functional team
    Supervisory Responsibilities:
    • May supervise or provide guidance to more junior engineering or technician staff
    Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

    Salary Range: $189,000-$208,000/annually

    Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer.

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