Principal Member of Technical Staff - Medical Device Software

As a Principal Member of Technical Staff, you will be a key contributor to the development of and governing the software architecture and compliance framework for regulated medical devices. This role bridges product development, regulatory, and enterprise architecture functions—ensuring that device software solutions are designed securely, maintain regulatory compliance, and align with enterprise standards and long-term technology strategy.

You will guide product teams in interpreting and applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, and support the adoption of compliant SDLC processes and tooling.

Deep understanding of medical device software regulations and standards along with a proven experience defining and building secure, complaint and scalable architectures for safety-critical systems is a must.

Responsibilities:

As a Principal Member of Technical Staff for Medical Device Software, your key responsibilities include:

• Architectural Leadership & Governance
  • Serve as the designated Enterprise Architect for one or more regulated medical devices, defining the software architecture and integration strategy in alignment with enterprise and product-level requirements.
  • Define and manage software and system interfaces, ensuring end-to-end traceability from requirements through implementation and verification.
  • Partner with product and platform teams to ensure software designs are aligned with device-level safety, performance, and compliance needs.
• Regulatory Compliance & Quality Alignment
  • Ensure adherence to medical device software standards including IEC 62304 (software lifecycle) and IEC 82304 (health software product safety and effectiveness).
  • Embed regulatory and quality requirements into the architecture and development lifecycle, enabling teams to maintain compliance through automated traceability and documentation.
  • Support audits, technical documentation, and risk management activities by providing architectural artifacts and compliance evidence.
• Secure Design & Risk Management
  • Drive implementation of secure-by-design principles across all device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations.
  • Apply the organization's Risk-Based Process to ensure consistent evaluation, mitigation, and documentation of software-related risks.
• Cross-Functional Collaboration
  • Partner closely with Regulatory, Quality, and Security teams to align technical and compliance processes with evolving global requirements.
  • Collaborate with SDLC tooling and DevOps teams to ensure development environments, CI/CD pipelines, and configuration management systems support regulatory traceability and validation.
  • Provide architectural and compliance mentorship to product teams, enabling them to take ownership of compliant design and documentation practices.
• Continuous Improvement
  • Champion architectural best practices, technical governance, and scalable design patterns across the organization's medical device portfolio.
  • Identify opportunities to streamline compliance activities through improved tooling, automation, and architectural consistency.

Qualifications:

• Education
  • Bachelor's or Master's degree in Computer Science, Software Engineering, or a related technical field.
• Experience
  • Minimum of 8+ years of professional software engineering experience, including significant responsibility for designing and governing architectures in complex, safety- or compliance-critical systems (medical device experience preferred).
• Technical Expertise
  • Deep proficiency in Java, Python, or similar object-oriented languages, with proven ability to design and implement secure, scalable, and maintainable systems.
  • Strong grounding in software engineering fundamentals—including algorithms, data structures, microservices, and RESTful APIs.
  • Advanced understanding of system and distributed architecture design, including data flow, integration patterns, and fault-tolerance strategies.
  • Proven ability to define and enforce architecture governance and traceability across the software development lifecycle (SDLC).
•  Regulatory & Compliance Knowledge
  • Working knowledge of medical device software standards such as IEC 62304, IEC 82304, and relevant FDA guidance.
  • Proven ability to apply regulatory requirements to software design, documentation, and development practices.
  • Experience defin