Sr. Systems Integration and Test Engineer - Pleasanton, CA jobs in United States
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Calyxo, Inc. · 4 hours ago

Sr. Systems Integration and Test Engineer - Pleasanton, CA

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA, focused on improving kidney stone treatment. They are seeking a highly skilled and innovative Sr. Systems Integration and Test Engineer to design and build advanced R&D test fixtures, execute verification strategies, and drive system-level integration testing for next-generation kidney stone treatments.

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H1B Sponsor Likelynote

Responsibilities

Independently design, build, and validate fluidic, mechanical, and optical R&D test fixtures
Own the full lifecycle of fixtures: creative concept, CAD (SolidWorks), fabrication coordination, hardware integration, data acquisition, and refinement
Integrate sensors for pressure, flowrate, vacuum, optical metrics, and other key performance parameters
Develop light Python scripts for data processing, device interaction, and basic automation
Own system-level integration testing for the endoscopic platform
Lead development of performance-focused test methods, especially around fluidics and clinical-relevant behaviors
Create and execute verification plans at the system and subsystem level in coordination with design and development teams
Work within a phase-gated (waterfall) program while helping drive agile testing practices inside R&D
Collaborate with systems architects to define, refine, and quantify system requirements
Ensure requirements are measurable, testable, and clinically relevant
Support development and evolution of traceability matrices, verification protocols, and engineering documentation
Partner with clinical engineering to develop methods for capturing essential data from benchtop biologic and ex vivo models
Support occasional large-animal lab activities as needed to evaluate integrated system performance
Work closely with teams across mechanical, electrical, firmware, systems, quality, and clinical engineering
Serve as a key technical voice representing test and integration considerations in design reviews and architecture decisions

Qualification

Fluidics expertiseData acquisition systemsSolidWorks proficiencyMedical device standardsPython scriptingTest method developmentCross-functional collaborationProblem-solving skillsTechnical writingCommunication skills

Required

Bachelors degree in Mechanical or Biomedical Engineering
7+ year's experience
Demonstrated expertise in fluidics or vacuum-based systems
Strong hands-on experience with: Data acquisition systems, Fluidic and vacuum test equipment, Instrons or mechanical pull/force systems, Sensors for pressure, flowrate, and mechanical metrics
SolidWorks proficiency (designing fixtures, assemblies, and test hardware)
Python scripting for data processing and basic device/fixture control
Deep familiarity with medical device standards and quality systems (e.g., 60601-1, 62366-1, 62304), especially as they relate to performance testing and verification
Ability to independently drive fixture design, test method development, and system integration activities with minimal oversight
Excellent communication and cross-functional collaboration skills
Strong problem-solving skills and experience working as part of multifunctional technical project teams through all development lifecycle phases
Experience in requirements definition, design verification, change management and risk control
Excellent technical writing and verbal communication skills
Ability to work independently or in a team setting required
Must be self-directed, self-motivated and be able to multi-task in a fast-paced environment with multiple priorities
Knowledge and ability to interpret and follow applicable regulations, guidelines, and policy statements is required
Must have experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD
Travel: Minimal, less than 5%
Work location: Pleasanton (Rosewood), on-site 4-5 days a week

Preferred

Masters or PhD preferred

Benefits

Stock options – ownership and a stake in growing a mission-driven company
Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Company

Calyxo, Inc.

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Calyxo, Inc.

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 Stage
Total Funding
$125.44M
Key Investors
Avidity Partners
2024-12-26Series Unknown· $28.28M
2023-12-12Series D· $50M
2022-07-06Series C· $32.7M

Leadership Team

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Joseph Catanese
President & CEO
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Doug Hughes
CFO (Calyxo Inc)
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Company data provided by crunchbase