Lead Principal Systems Engineer – NGS & V&V Expert

Roche Holding AG

Santa Clara (CA)

Hybrid

USD 127,000 - 237,000

Full time

14 days+

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Job summary

Roche Holding AG in Santa Clara is seeking a Principal Systems Engineer II to lead cross-functional verification and validation efforts for next‑generation sequencing platforms. You will manage hardware, software, firmware interfaces and drive AI-assisted testing, while guiding design assessments and risk strategies.

This role demands deep NGS domain knowledge, strong systems engineering mastery, and collaboration with Quality, Regulatory, and Operations teams.

Qualifications

10+ years of related experience or MS + 9 years or PhD + 6 years in relevant field.
Experience leading full-scale verification campaigns and regulatory-aligned testing.
Mastery of end-to-end systems engineering processes and architecture development.
Deep hands-on background in NGS platforms, molecular diagnostics, or nucleic acid-based tech.
Proficiency with requirements management tools (HPALM, RETINA) and ISO 14971/FMEA/PFMEA risk standards.

Responsibilities

Lead cross-functional V&V campaigns for next-gen sequencing platforms.
Draft, review, and execute test cases; drive AI-assisted test generation.
Architectural/design assessment for requirement coverage and reliability.
Serve as SME for complex instrument troubleshooting and non-compliance resolution.
Mentor junior engineers and influence across Quality, Regulatory, Operations, and IT services.
Oversee multi-site environmental chamber studies and hardware testing including EMI/EMC.