Calyxo, Inc. · 1 day ago
Sr. R&D Engineer, Instruments - Pleasanton, CA
Pleasanton, CA
Full-time
Onsite
Mid, Senior Level
$135K/yr - $165K/yr
4+ years expCalyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA, focused on improving kidney stone treatment. The role involves driving the design and development of innovative instruments and accessories for kidney stone treatment, collaborating with cross-functional teams to bring concepts from development to commercialization.
Health CareMedicalMedical DeviceWellness
Responsibilities
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 new designs or processes, working in partnership with other teams across the organization to gain alignment
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
Effectively communicate project progress, results, and risks to relevant stakeholders
Develop and validate verification test methods, create and execute protocols, and author associated reports and risk documentation
Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing, ensuring alignment with project goals and timelines
Qualification
Required
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 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 injection molding and one or more of the following key areas: 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
Experience in product development within regulated industries and knowledge of sterilization and biocompatibility testing
Benefits
Stock options – ownership and a stake in growing a mission-driven company
Employee benefits package that includes 401(k), healthcare insurance and paid time off
Company
Calyxo, Inc.
Calyxo, Inc.
201-500 employees
H1B Sponsorship
Calyxo, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Late StageTotal Funding
$125.44MKey Investors
Avidity Partners
2024-12-26Series Unknown· $28.28M
2023-12-12Series D· $50M
2022-07-06Series C· $32.7M
Leadership Team
Joseph Catanese
President & CEO
Doug Hughes
Chief Financial Officer
Recent News
2025-12-18
2025-10-21
Medical Product Outsourcing
2025-09-13
Company data provided by crunchbase