Systems Engineer jobs in United States
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Petal Surgical · 8 hours ago

Systems Engineer

Petal Surgical is on a mission to make incisionless surgery the standard of interventional care. The Systems Engineer will define, integrate, and verify complex electromechanical and control systems used to enable incisionless surgery, ensuring robust system-level performance through collaboration with cross-functional teams.

Health CareHospitalMedical

Responsibilities

Develop and maintain system and subsystem requirements derived from clinical use cases, safety analyses, and design inputs
Define system architecture and interfaces between hardware, software, and control elements to ensure reliable and safe operation
Lead functional hazard analyses, risk mitigation planning, and risk analysis activities in accordance with ISO 14971
Establish traceability across requirements, mitigations, and verification activities using a requirements management tool
Plan and execute system verification strategies including test method development, test fixture definition, and acceptance criteria
Working knowledge of 60601-1 and collateral standards
Author and review verification and validation protocols and reports to demonstrate compliance with intended use and performance requirements
Collaborate with mechanical, electrical, and software engineers to diagnose and resolve integration issues during system build and test
Support design reviews, provide technical risk assessments, and ensure fulfillment of design control documentation per FDA 21 CFR 820
Analyze verification data, summarize system performance, and recommend design or process improvements
Contribute to continuous improvement of system engineering practices, toolchains, and documentation standards
Support the Technology Lead in developing and maintaining technology platform level requirements derived from clinical use cases, safety analyses, and design inputs to support a multigenerational strategic R&D roadmap
Support the Technology Lead in defining system architecture and interfaces between hardware, software, and control elements to support a multigenerational strategic R&D roadmap
Serve as a bridge between the multigenerational strategic R&D roadmap and the current product development program

Qualification

Systems EngineeringISO 14971Electromechanical DesignRisk ManagementRegulatory ComplianceCollaborationProblem SolvingCommunication

Required

Bachelor's degree in Systems Engineering or a related area
At least 5 years of relevant work experience in a regulated environment with safety critical requirements
Experience working in an ISO14971 risk management environment
Experience taking a system through successful compliance testing
Completed at least one complex electromechanical design verification cycle through to human use
Ability to work with minimal supervision within an environment rich with unsolved science and technology challenges, hazy requirements, and a dynamic team committed to changing the fundamentals of surgery

Preferred

Master's degree in Systems Engineering, Computer Science, Electrical Engineering or a related area
At least 10 years of relevant experience in a systems engineering role for a safety critical medical device
Successfully completed multiple medical device design verification cycles through to human use
Experience creating an ISO14971 compliant environment
Ability to work independently and autonomously within an environment rich with unsolved science and technology challenges, hazy requirements, and a dynamic team committed to changing the fundamentals of surgery

Company

Petal Surgical

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It's time, to make healing human.

Funding

Current Stage
Early Stage
Total Funding
$27.68M
2025-10-20Series A· $10M
2025-08-29Series Unknown· $8.02M
2025-08-29Debt Financing· $9.66M

Leadership Team

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Prash Chopra
Founding CEO & Special Ops (Technology & Execution)
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Bowen Jiang, MD
Co-Founder
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Company data provided by crunchbase