Software/Hardware Compliance Engineer

We are seeking an experienced Quality Engineer to manage creation of quality deliverables on a diagnostic instrument design project which includes software development and IEC 62304 compliance. This role ensures the integration of quality into both hardware and software design processes, maintaining compliance with regulatory standards such as ISO 13485, FDA 21 CFR Part 820, and IEC 62304. The successful candidate will work cross-functionally to ensure the diagnostic system meets all applicable safety, performance, and regulatory requirements.

Key Responsibilities:

Lead and coordinate quality engineering deliverables for both hardware and software components of diagnostic instrument design projects.

Ensure software development processes comply with IEC 62304, including software risk classification, software requirements traceability, verification, and validation planning.

Collaborate closely with Software Engineering, Systems Engineering, and Regulatory Affairs teams to ensure design controls for software are fully implemented.

Support the development, review, and approval of Software Development Plans, Software Requirements Specifications (SRS), Software Architecture, V&V Protocols, and associated quality documentation.

Facilitate and participate in comprehensive risk management activities, including software-specific risk analysis in accordance with ISO 14971 and IEC 62304.

Maintain traceability matrices ensuring linkage between software requirements, design inputs/outputs, risk controls, and V&V activities.

Ensure that software risk mitigations are properly documented, tested, and verified.

Review and approve software test plans, protocols, and reports, ensuring alignment with user needs, intended use, and regulatory standards.

Provide quality oversight of software change control processes during development and post-market phases.

Participate in and lead design reviews, ensuring both hardware and software quality risks are addressed and resolved.

Ensure compliance with IEC 60601 (electrical safety) and IEC 62366 (usability) standards, as applicable.

Prepare and support documentation for regulatory submissions (e.g., FDA 510(k), CE Mark Technical File) and external audits.

Qualifications:

Bachelor’s degree in Engineering (Software, Systems, Biomedical, Electrical, or related field).

10+ years of experience in quality engineering for medical devices or diagnostic instruments,

Strong working knowledge of IEC 62304 and ISO 14971 required.

Familiarity with software risk management, software architecture documentation, and verification strategies.

Experience with software/hardware integration projects in the medical device or diagnostics field preferred.

Knowledge of additional standards such as IEC 60601, IEC 62366, and cybersecurity guidance (FDA, IMDRF) is a plus.

Demonstrated ability to lead software-related risk management and quality planning activities.

Excellent organizational, communication, and leadership skills.

Preferred:

Experience with in vitro diagnostic (IVD) systems.

Experience supporting regulatory submissions involving software-based medical devices.