Principle Systems Engineer II

Roche•Santa Clara, CA

2d•$127,300 - $236,500•Hybrid

About The Position

At Roche, we foster a culture where you can be yourself, embraced for your unique qualities. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted, and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop, and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. As a Principal Systems Engineer II within our System Development & Integration team, you will serve as a key technical leader and Subject Matter Expert (SME) driving the systems engineering, integration, compliance, and verification efforts for our next-generation sequencing (NGS) platforms. In this role, you will matrix-manage cross-functional verification teams and navigate complex system dynamics across hardware, software, firmware, and chemistry/assay interfaces.

Requirements

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.
Demonstrated success leading full-scale system verification campaigns, environmental chamber studies, and diagnosing issues identified
Proven expertise in end-to-end systems engineering processes, including architecture development, interface definition, error budgeting, Ad-Hoc Testing & Troubleshooting.
Deep hands-on background in Next-Generation Sequencing (NGS) platforms, molecular diagnostics, and nucleic acid-based technologies.
Proficiency with requirements management tools (e.g., HPALM, RETINA) and medical device risk management standards (ISO 14971, FMEA/PFMEA).

Nice To Haves

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.

Responsibilities

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.
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.
Evaluate and critique design concepts for requirements coverage, feasibility, reliability, modularity, risk, and serviceability early in the platform lifecycle.
Serve as the primary technical escalation point and SME for complex instrument troubleshooting, non-compliance resolution, and system-level issue translation.
Mentor junior systems engineers and technicians while serving as a strategic technical voice across Quality, Regulatory, Operations, and International Technical Services.
Oversee multi-site environmental chamber studies and hardware compliance testing, including EMC/EMI testing with third-party partners (e.g., Intertek).
Establish, manage, and write Design History File (DHF) deliverables, Solution-Level Installation Guides, and Installation/Operational Qualification (IOQ) procedures.