Senior Systems Engineer — NGS & V&V Lead (Hybrid)

Roche; Santa Clara (CA); Hybrid; USD 127,000 - 237,000; Full time

Job summary

Roche seeks a Principal Systems Engineer II in Santa Clara to lead verification and validation for next-gen sequencing platforms. You will matrix-manage cross-functional teams across hardware, software, firmware, and chemistry interfaces, driving advanced test engineering and risk management.

Qualified candidates have a strong NGS background, experience with regulatory standards, and a track record in delivering complex medical device verification programs.

Qualifications

• 10 years of related experience or MS + 9 years; or PhD + 6 years.
• Experience leading full-scale verification campaigns.
• Deep NGS, molecular diagnostics background.

Responsibilities

• Lead V&V campaigns across cross-functional teams for complex NGS platforms.
• Draft, review, execute test cases; diagnose issues with stakeholders.
• Evaluate design concepts for requirements coverage and risk.
• Serve as SME for complex instrument troubleshooting and compliance.
• Mentor junior engineers and influence acrossQuality, Regulatory, Ops, and ITS.
• Oversee environmental chamber studies and EMC/EMI testing with partners.
• Own DHF deliverables and Installation/Operational Qualification docs.

Skills

V&V leadership

Systems engineering

NGS platforms

Regulatory compliance

Risk management

Mentorship

Education

MS in related discipline

PhD in related discipline

Tools

HPALM

RETINA

Job description

Roche seeks a Principal Systems Engineer II in Santa Clara to lead verification and validation for next-gen sequencing platforms. You will matrix-manage cross-functional teams across hardware, software, firmware, and chemistry interfaces, driving advanced test engineering and risk management.

Qualified candidates have a strong NGS background, experience with regulatory standards, and a track record in delivering complex medical device verification programs.