Senior R&D Sustaining Engineer, Instruments - Pleasanton, CA

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 from concept to launch and beyond We are looking for a Senior R&D Sustaining Engineer to drive design solutions and support process enhancements for commercialized products, working closely alongside the systems, vision and sensors, and software R&D teams, to catalyze the advancement of an innovative, single-use kidney stone treatment devices. 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 integrate and implement these 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/or external feedback.
• Lead design-related root cause analysis efforts, and drive corrective and preventive actions.
• Serve as an R&D SME for projects lead by cross-functions, and partner with cross-functional teams to gain alignment on qualification strategies.
• Create prototypes, design fixturing, devise feasibility studies, and execute testing to draw meaningful conclusions and guide product development.
• Collaborate with the Post-Market Surveillance team to support effective root cause analysis of device issues returning from the field.
• 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.
• Support the generation of new or revised product requirements and engineering specifications.
• Create and execute protocols, and author associated reports and risk documentation, developing and validating new test methods as needed.
• Effectively communicate project progress, results, and risks to relevant stakeholders.
• Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing as needed, ensuring alignment with project goals and timelines.

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 designs that can scale.
• 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 stage through to design maturation.
• Proven design capabilities in two or more of the following key areas: injection molding, electro-mechanical sub-systems, catheter construction, endoscope construction, fluidics.
• Experience creating and running simulations (CFD, FEA) to inform product development.
• Solid experience conducting structured design of experiments (DOEs) and using statistical methods to analyze data.
• Strong collaboration and communication skills, with the ability to work effectively on cross-functional teams.
• Strong problem-solving and analytical skills, with a hands-on approach to product development and testing.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes: