Calyxo
Senior R&D Sustaining Engineer, Instruments - Pleasanton, CA
Calyxo, Pleasanton, California, United States, 94566
Senior R&D Sustaining Engineer, Instruments - Pleasanton, CA
Pleasanton, CA
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California. 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 track record of commercializing paradigm-shifting devices in urology.
Overview
The Instruments Engineering team develops and drives Calyxo’s instruments and accessories from concept to launch and beyond. We are seeking a Senior R&D Sustaining Engineer to drive design solutions and support process enhancements for commercialized products, collaborating with systems, vision and sensors, and software R&D teams to advance single-use kidney stone treatment devices. You will work with cross-functional partners in Manufacturing, Quality, Marketing, Clinical, and Regulatory to implement solutions into our commercialized product(s).
In This Role, You Will
Lead and inform the design, development and qualification strategy for design-related product enhancements and line extensions in response to internal and external feedback.
Lead design-related root cause analysis efforts, and drive corrective and preventive actions.
Serve as an R&D SME for cross-functional projects, and partner with teams to align qualification strategies.
Create prototypes, design fixturing, perform feasibility studies, and execute testing to guide product development.
Collaborate with Post-Market Surveillance to support root cause analysis of field issues.
Ensure adherence to the design control process and enable manufacturability, reliability, and scalability.
Use SolidWorks to create models, assemblies, and drawings.
Support the generation of new or revised product requirements and engineering specifications.
Create and execute protocols, and author reports and risk documentation; develop and validate new test methods as needed.
Communicate project progress, results, and risks to stakeholders.
Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing as needed.
Who You Will Report To
See Organizational Chart
Requirements
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field
5+ years of medical device experience (4+ with an advanced degree)
Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820
Ability to apply DFX principles to create scalable designs
Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance stack analysis, and GD&T
Track record of taking design concepts from prototyping to maturation
Proven design capabilities in two or more of: injection molding, electro-mechanical sub-systems, catheter construction, endoscope construction, or fluidics
Experience creating and running simulations (CFD, FEA) to inform development
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 analytical skills in product development and testing
Compliance with relevant vaccination requirements
What We Offer
At Calyxo, you will be part of a knowledgeable, high-achieving team in a diverse environment. You will have opportunities to grow and contribute to our culture and mission, with a compensation package that includes a competitive base salary, an incentive plan, stock options, and benefits (401(k), healthcare, paid vacation).
Equal Opportunity
Calyxo is proud to be an equal opportunity employer. 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 other legally protected characteristics. Legal authorization to work in the United States is required.
Disclaimer
We prioritize a structured interview process. This includes multiple interview stages with Calyxo employees to ensure mutual fit. We do not extend job offers without meeting candidates, virtually or in person. Be aware of potential scams; Calyxo will never request sensitive information via email or online forms before an official interview. Official communications will come from @calyxoinc.com.
#J-18808-Ljbffr
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California. 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 track record of commercializing paradigm-shifting devices in urology.
Overview
The Instruments Engineering team develops and drives Calyxo’s instruments and accessories from concept to launch and beyond. We are seeking a Senior R&D Sustaining Engineer to drive design solutions and support process enhancements for commercialized products, collaborating with systems, vision and sensors, and software R&D teams to advance single-use kidney stone treatment devices. You will work with cross-functional partners in Manufacturing, Quality, Marketing, Clinical, and Regulatory to implement solutions into our commercialized product(s).
In This Role, You Will
Lead and inform the design, development and qualification strategy for design-related product enhancements and line extensions in response to internal and external feedback.
Lead design-related root cause analysis efforts, and drive corrective and preventive actions.
Serve as an R&D SME for cross-functional projects, and partner with teams to align qualification strategies.
Create prototypes, design fixturing, perform feasibility studies, and execute testing to guide product development.
Collaborate with Post-Market Surveillance to support root cause analysis of field issues.
Ensure adherence to the design control process and enable manufacturability, reliability, and scalability.
Use SolidWorks to create models, assemblies, and drawings.
Support the generation of new or revised product requirements and engineering specifications.
Create and execute protocols, and author reports and risk documentation; develop and validate new test methods as needed.
Communicate project progress, results, and risks to stakeholders.
Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing as needed.
Who You Will Report To
See Organizational Chart
Requirements
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field
5+ years of medical device experience (4+ with an advanced degree)
Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820
Ability to apply DFX principles to create scalable designs
Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance stack analysis, and GD&T
Track record of taking design concepts from prototyping to maturation
Proven design capabilities in two or more of: injection molding, electro-mechanical sub-systems, catheter construction, endoscope construction, or fluidics
Experience creating and running simulations (CFD, FEA) to inform development
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 analytical skills in product development and testing
Compliance with relevant vaccination requirements
What We Offer
At Calyxo, you will be part of a knowledgeable, high-achieving team in a diverse environment. You will have opportunities to grow and contribute to our culture and mission, with a compensation package that includes a competitive base salary, an incentive plan, stock options, and benefits (401(k), healthcare, paid vacation).
Equal Opportunity
Calyxo is proud to be an equal opportunity employer. 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 other legally protected characteristics. Legal authorization to work in the United States is required.
Disclaimer
We prioritize a structured interview process. This includes multiple interview stages with Calyxo employees to ensure mutual fit. We do not extend job offers without meeting candidates, virtually or in person. Be aware of potential scams; Calyxo will never request sensitive information via email or online forms before an official interview. Official communications will come from @calyxoinc.com.
#J-18808-Ljbffr