Sr. Software Engineer

Job Summary:

The Electronics Assembly Engineer is responsible for performing and supporting electronic assembly activities for medical devices and related products while ensuring compliance with approved procedures, quality standards, and production requirements.

Key Responsibilities:

• Design, develop, and maintain embedded and/or application-level software for medical devices,
• Work closely with hardware, electrical, and systems engineering teams to define software architecture and interfaces for the device.
• Implement and optimize core algorithms relevant to the device's function (e.g., signal processing, sensor data handling, control logic, or data analytics).
• Ensure software complies with applicable medical device standards and relevant regulatory frameworks.
• Integrate with healthcare data/interoperability standards where applicable (e.g., DICOM, HL7, FHIR) if the device connects to hospital systems such as PACS/RIS/EMR.
• Participate in requirements analysis, architecture design, code reviews, unit/integration testing, and verification & validation (V&V) activities.
• Maintain thorough documentation (SRS, SDD, risk management files, traceability matrices) required for regulatory submissions and audits.
• Support root-cause analysis and debugging of field or system-level issues, balancing performance, safety, and reliability.
• Contribute to software risk analysis (FMEA) and participate in design reviews.
• Mentor junior engineers and help establish coding standards and engineering best practices within a regulated environment.

Qualifications:

Bachelor's or Master's degree in Computer Science or related field with 10+ years of experience.

Experience & Skills:

• Strong programming skills in one or more of: C, C++, C#, Python, or Java, depending on whether the role is embedded/real-time or application-focused.
• Solid understanding of software development for regulated, safety-critical systems, including the medical device software lifecycle (IEC 62304) or equivalent standards from other regulated domains.
• Familiarity with risk management principles and how they translate into software design and testing decisions.
• Experience with version control (Git/SVN), CI/CD pipelines, and static/dynamic code analysis tools.
• Experience writing and executing unit/integration tests and producing V&V documentation suitable for audits.
• Ability to read and work from formal requirements and design documents typical of regulated product development.

Regulatory & Quality Knowledge:

• Working knowledge of at least one major regulatory framework relevant to medical devices (FDA 21 CFR Part 820, ISO 13485, IEC 60601-1, EU MDR) direct experience is a strong plus even if gained on a different type of device.
• Comfortable working within an audit-ready, document-controlled QMS environment.

Good to Have (Not Mandatory):

• Domain experience with a specific device category e.g., imaging, patient monitoring, diagnostics, implantable, or connected/IoT medical devices — used here only as illustrative examples, not a restrictive requirement.
• Exposure to healthcare interoperability standards (DICOM, HL7, FHIR) if relevant to the product.
• Experience with real-time operating systems (RTOS) or embedded Linux
• Exposure to AI/ML-based features in a regulated software context.
• Familiarity with medical device cybersecurity requirements (e.g., IEC 81001-5-1, FDA premarket cybersecurity guidance).
• Certification in Medical Device Software Development, Regulatory Affairs, or a related field.