Senior Software Design Assurance Engineer

Knowledge

• In-depth understanding of medical device regulations (e.g., FDA, EU MDR, ISO 13485, IEC 62304) for Software as a Medical Device (SaMD) and embedded systems.
• Strong grasp of the software development lifecycle (SDLC) and its application to safety-critical systems.
• Expertise in risk management per ISO 14971, including Hazard Analysis and FMEA.
• Familiarity with usability principles and IEC 62366 to enhance product safety and effectiveness.
• Knowledge of regulatory and safety challenges for AI/ML in medical devices.
• Proficiency in statistical software (e.g., Minitab) for data analysis.

Skills

• Ability to mature Quality Management System (QMS) processes using Agile/iterative design controls.
• Hands-on experience in full SDLC for safety-critical applications.
• Defining and executing robust software verification and validation (V&V) strategies.
• Integrating automated testing into CI/CD pipelines and leveraging data analytics for continuous improvement.
• Advanced project documentation, requirements management, and version control.
• Software security skills, including threat modeling, vulnerability assessments, and penetration testing.
• Excellent communication for cross-functional collaboration and technical presentations.

Behavior

• Collaborative approach, working closely with cross-functional teams (R&D, Regulatory, Marketing, Manufacturing Engineering, Quality Engineering).
• Leadership in guiding teams on best practices for software development and compliance.
• Proactive in identifying process gaps, recommending improvements, and supporting continuous improvement initiatives.
• Creative and effective problem-solving, ensuring innovative solutions without compromising quality or compliance.
• Commitment to maintaining compliance with all regulatory requirements and internal policies.

Experience

• Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, or related discipline with 5+ years of medical device industry experience, or a Master’s degree with 3+ years of experience.
• Proven track record in applying medical device regulations and standards to software projects.
• Experience in leading design assurance activities, risk management, verification, and validation throughout the product lifecycle.
• Participation in new product development and sustaining product projects, ensuring clear scope and objectives are met.
• Involvement in regulatory inspections and remediation initiatives.