Senior Software Engineer - Embedded Systems (Medical Devices)

About the Role

A fast-growing, mission-driven medical device organization is seeking a Senior Software Engineer to lead the development of embedded software for next‑generation regulated devices. This role is ideal for an engineer who thrives in cross-functional environments, enjoys solving complex technical problems, and wants to contribute to products that directly impact patient outcomes. You will design and maintain embedded software components that interface with electromechanical and sensing systems, including advanced optical and real‑time data acquisition technologies. The role includes significant influence on architecture, compliance, documentation, and cross-team collaboration.

Key Responsibilities

• Design, develop, and maintain scalable, high‑performance embedded software for regulated medical or scientific systems.
• Write clean, well‑documented code and algorithms with emphasis on signal processing, spectral analysis, and device control.
• Lead architecture discussions, software reviews, and debugging efforts.
• Integrate software with electrical, mechanical, and sensor subsystems (including optical or spectrometry-based components).
• Ensure compliance with applicable medical device standards (e.g., IEC 62304, ISO 13485, FDA 21 CFR Part 820).
• Manage a version-controlled code repository (e.g., Git) supporting traceability and collaborative development practices.
• Create and maintain software documentation: architecture, requirements, verification plans, design specifications, and traceability matrices.
• Contribute to cybersecurity activities including threat modeling, SBOMs, and risk assessments aligned with current FDA guidance.
• Collaborate closely with product managers, QA, hardware teams, and clinical stakeholders to translate user needs into reliable software solutions.
• Support verification and validation efforts including unit, integration, and system testing.
• Participate in problem solving, root-cause analysis, and product improvements.
• Coordinate with external development partners when needed.
• Stay current with emerging technologies and recommend process or product improvements.

Qualifications

• Bachelor's or Master's degree in Computer Science, Electrical Engineering, Biomedical Engineering, or related discipline.
• 5+ years of experience developing embedded software for medical devices, scientific instrumentation, or similarly regulated/hardware-integrated systems.
• Strong proficiency in algorithm development, signal processing, and embedded system design.
• Experience developing in C++ on Linux-based platforms (Yocto) (or similar embedded environments).
• Familiarity with regulatory frameworks such as IEC 62304, ISO 13485, and FDA QSR.
• Proven ability to create clear technical documentation for design, requirements, and verification.
• Ability to manage SBOMs (software bill of materials) in conjunction with cybersecurity standards
• Effective communication skills and ability to collaborate with multidisciplinary teams.

Experience with optical sensors, spectrometers, or real‑time data acquisition systems is a plus. Prior involvement in FDA submissions, CE marking, or regulated product development is strongly preferred.