Senior Device Quality Engineer

Role

As the Senior Device Quality Engineer, you will serve as a key technical lead for software quality and design excellence. You will bridge the gap between rapid Agile development and rigorous medical device regulations, ensuring that our digital health solutions—including Software as a Medical Device (SaMD) and AI/ML-enabled technologies—are safe, secure, and compliant.

Key Responsibilities

Technical Leadership

• Standards Execution: Apply global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45, to daily development activities.
• SDLC Support: Implement validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1) within the Quality Management System (QMS).
• Agile Integration: Partner with engineering teams to execute "Compliance at Speed," ensuring Agile sprints meet all regulatory rigor and result in high-quality, predictable releases.

Design Quality & Risk Management

• Design Reviews: Participate in software architecture reviews to ensure the implementation of safety-by-design and privacy-by-design principles.
• Risk Analysis: Facilitate and document comprehensive risk management activities, including Hazard Analysis, Fault Tree Analysis (FTA), and Software FMEAs.
• V&V Execution: Act as the lead for Software Verification and Validation (V&V); develop and execute test strategies, protocols, and reports to ensure product performance.

Execution & Compliance

• DHF Ownership: Manage the Design History File (DHF) from concept to commercialization, ensuring all documentation is audit-ready and design transfer is seamless.
• Audit Support: Support the organization during internal and external audits (e.g., FDA, Notified Body, MDSAP) as a subject matter expert for software processes.

Cross-Functional Collaboration

• Technical Documentation: Support Regulatory Affairs in authoring technical files for global submissions, including FDA (510k/De Novo), PMDA, and EU-MDR.
• Team Guidance: Provide technical coaching and quality training to R&D and Product teams to foster a culture of compliance.

Skills Needed

• Strong critical thinking skills and great attention to detail.
• Ability to work as a self-starter in a fast-paced, adaptive environment.
• Excellent communication, documentation, and time management skills.