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Overview
The Senior R&D Engineer will take a prototype second generation delivery system architecture into pilot production, DV testing, and to clinical trials. The candidate will work closely with the delivery system, operations, and implant teams to ensure a holistic product design and development approach. The candidate will facilitate engineering processes and product transfer to a cleanroom manufacturing environment.
Title
Senior R&D Engineer, Mechanical
Entity
Versa Vascular
Type
Onsite, 4+ days/week
Responsibilities
Work closely with R&D, manufacturing and clinical teams to bring a complex catheter-based delivery system to early clinical studies and beyond.Combine R&D and Manufacturing perspectives to implement elegant and practical changes.Figure out how to build the product, and then design to make better and more buildable:Empowered to change the design!Identify process gaps and inefficienciesDevelop suppliers to meet specificationsEvaluate, capture, and communicate the impact of implemented solutionsCommunicate system level integration challenges, support solution development and implementationUnderstand and prioritize between multiple workflows and feedback sourcesIdentify performance issues, track root causesDevelop and execute test methods to inform process and design decisionsAssist in development of product specificationsRequirements
BS in mechanical engineering or relevant field5+ years of relevant engineering experienceExperience with catheter based medical devices is strongly desiredProficiency in CAD, preferably SolidWorks, including 3D design and creation of technical printsExperience with various manufacturing methods, such as manual machining, 3D printing, MIM, molding, casting, laser welding, reflow, coatings, etc.Skills Desired
Demonstrated ability to take early designs into successful small-scale production and beyondHands on prototyping and testing experienceProficiency and familiarity with machining processes from simple on the fly reworks to guiding high level design for manufacturability decisionsFamiliarity with force sensing equipment (e.g. Chatillon, Instron) is a plusStrong organization and project management skillsHands-on experience working within a quality management system (QMS)Great troubleshooting skills and creative problem solvingAbility to compile results using applicable software (e.g. Excel, Minitab)Strong communication and collaborationSeniority level
Employment type
Job function
- Engineering and Information Technology
Industries
- Medical Equipment Manufacturing
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