- Design ownership of the consumable components of a fluidic system through new product development. This includes high pressure pumping and priming, flow control through a sensor driven architecture, and development of new hardware to improve safety and reliability.
- Lead external engineering consultants and collaborate directly with cross functional groups to define requirements for the fluidics platform, identify problem statements, brainstorm creative solutions, prototype systems, and iterate on the design for a production-ready solution.
- Assist or 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.
- Bachelor's degree in Engineering (Mechanical, Biomedical, or related discipline) with 8+ years of related experience or 6+ 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, in particular injection molding
- 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
- 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
- May supervise or provide guidance to more junior engineering or technician staff
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Staff Mechanical Engineer - Campbell, United States - Telos Health, Inc.
1 week ago
Description
Job Description
Job DescriptionJob Title: Staff 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.
Salary Range: $154,000-$162,000/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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