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