Job Description

LEAD SOFTWARE ENGINEER

ABOUT ASTRANU

AstraNu is a Seed-phase medical device startup that is bringing next-generation imaging

technology to market to transform middle-ear and hearing health. Powered by proprietary

breakthrough technology developed at Nokia Bell Labs, we are working to enhance,

accelerate, and streamline the diagnosis and treatment experience for patients and

physicians.

ABOUT THE ROLE

We are seeking an experienced Lead Software Engineer to design, build, and lead the

development of the core clinical-grade software system for our groundbreaking medical

imaging technology. This pivotal role will be instrumental in bringing our innovative device to

life, ensuring its performance, reliability, and strict adherence to medical device regulatory

standards. You will be responsible for de ning the software system architecture, making

critical technology choices, and leading implementation efforts for a system that directly

impacts patient care. This is an exceptional opportunity to become a foundational member of

our passionate and collaborative team in a fast-paced, mission-driven startup environment.

RESPONSIBILITIES

• Lead the design and full stack architecture of our medical imaging device software, including data acquisition, real-time image processing, user interface (UI/UX) for clinicians, and data management
• Define and document software engineering requirements, specifications, and design documents, ensuring scalability, performance, security, and maintainability across the system as well as compliance with medical regulations
• Own the SW portion of the Design History File (DHF) and Design Review (DR) processes: write and update software design inputs/outputs, lead formal code design reviews, and ensure Design Verification/Validation artifacts are captured in the DHF
• Make critical technology stack decisions (languages, frameworks, databases) appropriate for a high-performance, regulated medical device
• Integrate software development processes with medical device Quality Management System (QMS) requirements (e.g. ISO 13485, IEC 62304)
• Collaborate closely with Hardware, AI, Clinical, and Regulatory teams to ensure seamless system integration and alignment with product vision

REQUIRED EXPERIENCE

• 5+ years of experience in software engineering, with at least 2+ years in a technical leadership or lead engineer role
• Bachelor's or Master's degree in Computer Science, Software Engineering, Electrical Engineering, or a related technical field
• Proven experience designing, developing, and deploying software for medical devices, including deep understanding of medical device software lifecycle processes and standards (e.g., IEC 62304, ISO 13485, FDA 21 CFR Part 820)
• Hands-on experience developing and maintaining requirements traceability matrices (RTMs) to link system, software, and hardware requirements; creating and updating risk management files (FMEAs); and managing Engineering Change Orders (ECOs) to control BOM revisions and PCB updates
• Proficiency in key programming languages relevant to medical devices/imaging (e.g., C++, Python)
• Experience with real-time systems, image processing algorithms, and data visualization
• Excellent problem-solving, analytical, and debugging skills
• Strong communication and collaboration skills, with the ability to work effectively across interdisciplinary teams

• IDEAL EXPERIENCE
• Experience with large-scale data processing and streaming including GPU acceleration, multi-threading, and CPU optimization
• Knowledge of AI frameworks (PyTorch, TensorFlow, MONAI, etc) and experience with their deployment
• Direct experience with clinical-grade UI/UX design for medical professionals
• Familiarity with medical imaging standards (e.g., DICOM, HL7, FHIR)
• Prior experience in a startup environment, demonstrating adaptability and a proactive approach

LOCATION

In-office role at our HQ in Murray Hill, NJ

SALARY RANGE

$130k - $170k, plus stock options/equity package in a fast-growing startup

HOW TO APPLY

Please submit your resume and a cover letter explaining why you are the ideal candidate for

this role to  hiring@astranu.com

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