Calyxo
Sr. R&D Engineer, Instruments - Pleasanton, CA
Calyxo, Pleasanton, California, United States, 94566
Sr. R&D Engineer, Instruments - Pleasanton, CA
Pleasanton, CA Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the need for improved kidney stone treatment. 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. Overview
The Instruments Engineering team is responsible for developing and driving Calyxo’s instruments and accessories through to launch. You will drive the design and development of new solutions for released and next-generation critical components and accessories, integrating these solutions alongside the vision, sensors, and software R&D teams, to advance a single-use kidney stone treatment device. You will work with cross-functional partners in Manufacturing, Quality, Marketing, Clinical, and Regulatory to bring concepts through development to commercialization. Responsibilities
Create prototypes, design fixturing, conduct feasibility studies, and execute testing to guide product development. Ensure design and development pathways follow the design control process, enabling manufacturability, reliability, and scalability. Use SolidWorks to create models, assemblies, and engineering drawings. Solve engineering problems through root cause analysis and data-driven solutions. Define qualification strategies for new designs or processes, in partnership with other teams to gain alignment. Translate customer requirements into product requirements and engineering specifications. Coordinate with suppliers to progress component or subassembly development. Communicate project progress, results, and risks to stakeholders. Develop and validate verification test methods, create protocols, and document reports and risk documentation. Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing, aligning with project goals and timelines. Who You Will Report To
Sr. Vice President, Research & Development Qualifications
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field, and a minimum of 5 years of medical device experience, OR Advanced degree in a related field with 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 scalable designs Proficiency in SolidWorks with strong design-for-manufacturability, tolerance stack analysis, and GD&T Track record of taking design concepts from prototyping through design maturation Experience in injection molding and in at least one of: electro-mechanical sub-systems, catheter construction, endoscope construction, or fluidics Experience creating and running simulations (CFD, FEA) Experience conducting structured design of experiments (DOEs) and using statistical methods to analyze data Strong collaboration and communication skills for cross-functional work Hands-on problem-solving and testing approach to product development Experience in regulated industries and knowledge of sterilization and biocompatibility testing Work location: Pleasanton, CA; Travel:
Full-time employment Compliance with relevant vaccination requirements What We Offer
At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team in a diverse environment with opportunities to grow and shape our culture. Competitive base salary range of $135,000 - $165,000 and variable incentive plan Stock options – ownership and stake in a mission-driven company Employee benefits package including 401(k), healthcare insurance, and paid time off Equal Opportunity Employer
Calyxo is committed to fostering an environment where diversity and inclusion are valued and prioritized. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other legally protected characteristics. Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States. Disclaimer
Structured Interview Process: Our hiring process includes multiple stages of interviews to help you understand the role and our culture. Verification of Identity: We may meet candidates virtually or in person before offering a position. Beware of scams: Calyxo will never request sensitive personal information via email or online forms before an official interview. Contact info@calyxoinc.com to verify communications from a different domain.
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Pleasanton, CA Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the need for improved kidney stone treatment. 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. Overview
The Instruments Engineering team is responsible for developing and driving Calyxo’s instruments and accessories through to launch. You will drive the design and development of new solutions for released and next-generation critical components and accessories, integrating these solutions alongside the vision, sensors, and software R&D teams, to advance a single-use kidney stone treatment device. You will work with cross-functional partners in Manufacturing, Quality, Marketing, Clinical, and Regulatory to bring concepts through development to commercialization. Responsibilities
Create prototypes, design fixturing, conduct feasibility studies, and execute testing to guide product development. Ensure design and development pathways follow the design control process, enabling manufacturability, reliability, and scalability. Use SolidWorks to create models, assemblies, and engineering drawings. Solve engineering problems through root cause analysis and data-driven solutions. Define qualification strategies for new designs or processes, in partnership with other teams to gain alignment. Translate customer requirements into product requirements and engineering specifications. Coordinate with suppliers to progress component or subassembly development. Communicate project progress, results, and risks to stakeholders. Develop and validate verification test methods, create protocols, and document reports and risk documentation. Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing, aligning with project goals and timelines. Who You Will Report To
Sr. Vice President, Research & Development Qualifications
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field, and a minimum of 5 years of medical device experience, OR Advanced degree in a related field with 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 scalable designs Proficiency in SolidWorks with strong design-for-manufacturability, tolerance stack analysis, and GD&T Track record of taking design concepts from prototyping through design maturation Experience in injection molding and in at least one of: electro-mechanical sub-systems, catheter construction, endoscope construction, or fluidics Experience creating and running simulations (CFD, FEA) Experience conducting structured design of experiments (DOEs) and using statistical methods to analyze data Strong collaboration and communication skills for cross-functional work Hands-on problem-solving and testing approach to product development Experience in regulated industries and knowledge of sterilization and biocompatibility testing Work location: Pleasanton, CA; Travel:
Full-time employment Compliance with relevant vaccination requirements What We Offer
At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team in a diverse environment with opportunities to grow and shape our culture. Competitive base salary range of $135,000 - $165,000 and variable incentive plan Stock options – ownership and stake in a mission-driven company Employee benefits package including 401(k), healthcare insurance, and paid time off Equal Opportunity Employer
Calyxo is committed to fostering an environment where diversity and inclusion are valued and prioritized. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other legally protected characteristics. Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States. Disclaimer
Structured Interview Process: Our hiring process includes multiple stages of interviews to help you understand the role and our culture. Verification of Identity: We may meet candidates virtually or in person before offering a position. Beware of scams: Calyxo will never request sensitive personal information via email or online forms before an official interview. Contact info@calyxoinc.com to verify communications from a different domain.
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