Calyxo
Healthcare
Sr.R&DEngineer,Instruments
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr. R&D Engineer, Instruments at Calyxo. Skills: design and development of new solutions, integrating solutions, SolidWorks, root cause analysis, data-driven solution finding, qualification strategies, verification test methods. drive the design and development of new solutions for both released and next-generation critical components and accessories. integrating these solutions alongside the vision, sensors, and software R&D teams”
Industry & Context.
Effectively solve engineering problems through methodical root cause analysis and data-driven solution finding; problem-solving and analytical skills
Travel: less than 10%, Compliance with relevant county, state, and Federal rules regarding vaccinations, Legal authorization to work in the United States is required, Verification of Identity
What They're Looking For.
Must Have
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field, and a minimum of 5 years of medical device experience, OR Advanced degree in a related field and a minimum of 4 years of medical device experience, Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820, Ability to apply DFX principles to create designs that can scale, Proficiency in SolidWorks, understanding of design for manufacturability, understanding of tolerance stack analysis, understanding of GD& T, Track record of taking design concepts from prototyping stage through to design maturation, Proven design capabilities in injection molding, Proven design capabilities in electro-mechanical sub-systems, Proven design capabilities in catheter construction, Proven design capabilities in endoscope construction, Proven design capabilities in fluidics, Experience creating and running simulations (CFD, FEA) to inform product development, Solid experience conducting structured design of experiments (DOEs), using statistical methods to analyze data, collaboration and communication skills, problem-solving and analytical skills, hands-on approach to product development and testing, Experience in product development within regulated industries, knowledge of sterilization and biocompatibility testing, Legal authorization to work in the United States is required
Nice to Have
one or more of the following key areas: electro-mechanical sub-systems, catheter construction, endoscope construction, fluidics
What You'll Do.
drive the design and development of new solutions for both released and next-generation critical components and accessories
integrating these solutions alongside the vision
and software R&D teams
devise feasibility studies
execute testing to draw meaningful conclusions and guide product development
Ensure design and development pathways maintain adherence to the design control process
Define qualification strategies for new designs or processes
Meaningfully translate customer requirements into new or revised product requirements and engineering specifications
Drive communication with suppliers to progress activities relevant to component or subassembly development
Develop and validate verification test methods
create and execute protocols
author associated reports and risk documentation
Coordinate external testing activities such as sterilization
and biocompatibility testing
How You'll Work.
Team & Collaboration
integrating these solutions alongside the vision, sensors, and software R&D teams; immersed in a highly collaborative and multidisciplinary team; teaming up with cross-functional partners in Manufacturing, Quality, Marketing, Clinical, and Regulatory; working with cross-functional partners to enable manufacturability, reliability, and scalability; working in partnership with other teams across the organization to gain alignment; collaboration and communication skills; work effectively on cross-functional teams
Communication Scope
Effectively communicate project progress, results, and risks to relevant stakeholders; collaboration and communication skills
Process & Methodology
progress activities relevant to component or subassembly development, project goals and timelines
Full Job Description
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology. Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere. Summary: The Instruments Engineering team is a highly energetic and actively growing team that is responsible for developing and ultimately driving Calyxo’s instruments and accessories through to launch. In this role, you will drive the design and development of new solutions for both released and next-generation critical components and accessories, integrating these solutions alongside the vision, sensors, and software R&D teams, and catalyzing the advancement of an innovative, single-use kidney stone treatment device. You will be immersed in a highly collaborative and multidisciplinary team, teaming up with cross-functional partners in Manufacturing, Quality, Marketing, Clinical, and Regulatory to bring these novel concepts through all phases of development to commercialization. In this Role You Will: Create prototypes, design fixturing, devise feasibility studies, and execute testing to draw meaningful conclusions and guide product development. Ensure design and development pathways maintain adherence to the design control process, working with cross-functional partners to enable manufacturability, reliability, and scalability. Use SolidWorks to create well-defined models, assemblies, and engineering drawings. Effectively solve engineering problems through methodical root cause analysis and data-driven solution finding. Define qualification strategies for
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