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Principal R&D Engineer - Guidewire

Company: Telos Health, Inc.
Location: Campbell
Posted on: May 16, 2022

Job Description:

Job DescriptionAt 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. Telos is not only changing the way stroke is treated, but is also bringing this technology to the greater population who is currently without treatment options. We are actively building a team who is focused on developing novel solutions for this complex disease – a disease which one in four adults will face in their lifetime. Come join us on our mission to improve stroke intervention! Telos Health is a subsidiary of Imperative Care.SUMMARY: This position is responsible for design, development, and manufacturability of products/product line(s) and/or technical innovation of same; specifically, neuro-interventional guidewires and related accessories used in the Telos Health automated aspiration thrombectomy system. This position may be an individual technical innovation contributor or, as needed, supervise a technical team with responsibility for mentorship and development of other R&D engineers.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:

  • Ensure that assigned projects and/or products are designed to facilitate manufacturability and cost constraints, and lead technology transfer to manufacturing (to include development of manufacturing tools and/or aids)
  • Participate in and/or conduct animal, cadaver, and/or bench studies
  • Ensure that all products are designed, developed, and manufactured in compliance with the company Quality System, customer needs, budgetary requirements, schedule requirements and the regulatory requirements of the countries into which the products will be marketed
    • Develop concepts, prototypes, and detailed specifications, construction of prototypes for new products or current product enhancements; may be required to manage individual projects
      • Lead risk analysis activities and develop product testing plans and protocols; set up and run or lead product testing and protocols in accordance with project plans
      • Research and recommend vendor and/or contract developer/manufacturer, and material choices for products
      • Prepare and deliver status reports; ensure that product documentation is in accordance with Quality System requirements
      • Conceptualize and/or prototype new product designs, add-ons, or enhancements, through research, technical discussions, and interaction with SAB, Marketing, Clinical, and R&D team members,
      • Work directly with customer representatives, Marketing and Sales staff, and others to determine needs in product design, user interface, and possible integration of product with other medical systems or products
      • Conceptualize, design, and build prototypes and product modifications in response to bench testing, pre-clinical evaluations, and customer feedback
      • Strong working knowledge of relevant regulatory standards that apply to the specific product/project
      • Ensure technical activities are properly documented
      • Other duties as assignedGUIDEWIRE ENGINEERING
        • Work closely with other cross-functional team members to ensure the catheter and guidewire devices integrate seamlessly into the automated aspiration thrombectomy system and procedural workflow
        • Work with and develop relationships with outside contract development and manufacturing resources, as necessary
        • Work with Imperative Care R&D and Production groups and/or external resources, to ensure alignment of focus and ability to meet short and long-term guidewire build needs
        • Work with internal and/or external resources for guidewire coating needs
        • Set up and/or support Pilot manufacturing line(s) for guidewire, as necessary
        • Work with other functional groups to ensure seamless integration of guidewire into the automation drive system
        • Work with Packaging and Clinical groups to ensure guidewire is packaged in a robust manner and presented to users in a way that optimizes overall workflow
        • Identify and evaluate new guidewire opportunities based on customer inputs, new technologies, and brainstorming; initiate design and development efforts accordingly
        • Teach other engineers new techniques and testing techniques
        • Recommend and use anatomical models to evaluate performance characteristics of competitive and new guidewire designs; document the results and propose improvements based on this testing
        • Research specific clinical and device performance needs
        • Benchmark competitive devices to determine appropriate specifications
        • Develop design inputs, outputs in collaboration with Marketing personneEDUCATION/EXPERIENCE:
          • BS or MS in Engineering or related discipline and 10+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
          • 5+ years previous experience in technical innovation role, with specific focus on the design, development, manufacturing, and/or testing of guidewires, preferably neurovascular guidewires
          • Knowledge and experience with metals, metallurgic processing techniques, laser welding and machining, coiling, and PTFE and hydrophilic coating, as related to guidewires
          • Knowledge of and exposure to product testing and data collection
          • Extensive experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD
          • Extensive experience in full R&D product life cycle
          • Knowledge of relevant standards
          • Familiar with Design Control procedures and requirements
          • Excellent communications skills (both written and verbal) required
          • Ability to work independently or in team setting required
          • Must be able to travel extensivelyPowered by JazzHRmOfofCW0lA

Keywords: Telos Health, Inc., San Francisco , Principal R&D Engineer - Guidewire, Engineering , Campbell, California

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