Hiring: Principle Systems Engineer II Company: Roche Location: Santa Clara, CA Job Posted Time: 2026-09-03 10:33:21 Employment Type: Hybrid Target Skills & Keywords : Firmware, Regulatory Compliance About the job Experience: •10 years of related experience OR , MS degree in a directly related discipline + 9 years of related experience required; OR required, PhD degree in a directly related discipline + 6 years of related experience required. Required Skills: •V&V Campaign Leadership: Direct and matrix-manage cross-functional Verification & Validation (V&V) teams, leading the end-to-end execution of functional verification campaigns for complex NGS platforms •Advanced Test Engineering: Lead the drafting, reviewing, dry-running, and execution of test cases, in front of the sequencing solution. Diagnose Issues identified and work with stakeholders to resolve them, while driving the adoption of innovative tools such as AI-driven test case generation •Architectural & Design Assessment: Evaluate and critique design concepts for requirements coverage, feasibility, reliability, modularity, risk, and serviceability early in the platform lifecycle •Root Cause Analysis: Serve as the primary technical escalation point and SME for complex instrument troubleshooting, non-compliance resolution, and system-level issue translation •Mentorship & Cross-Functional Influence: Mentor junior systems engineers and technicians while serving as a strategic technical voice across Quality, Regulatory, Operations, and International Technical Services •Compliance & Specialized Testing: Oversee multi-site environmental chamber studies and hardware compliance testing, including EMC/EMI testing with third-party partners (e.g., Intertek) •Technical Documentation & DHF Ownership: Establish, manage, and write Design History File (DHF) deliverables, Solution-Level Installation Guides, and Installation/Operational Qualification (IOQ) procedures •V&V & Compliance Experience: Demonstrated success leading full-scale system verification campaigns, environmental chamber studies, and diagnosing issues identified Qualifications: •Demonstrated success leading AI-assisted test automation or advanced test generation methodologies •Advanced experience in IVD (In Vitro Diagnostics) submission environments and direct interaction with regulatory compliance bodies •Track record of matrix-managing multidisciplinary engineering teams in high-complexity medical device development •This role is based in Santa Clara and offers a hybrid schedule working 3-4 days per week on campus •No relocation benefits are available for this posting Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!